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    • wayne, pennsylvania
    • contract
    • US$30.00 - US$32.50, per hour, $30.00 - 32.50 per hour
    • 9 to 5
    job summary:The Project Support Specialist on the Global Strategic Research & Development team provides support to the Concept to Commercialization team to plan, prepare and execute technical documentation and project activities. Responsible for the creation and compliance of business process documentation in the PLM system. Assist in the planning and execution of projects under the direction of the project or technical lead. location: Wayne, Pennsylvaniajob type: Contractsalary: $30.00 - 32.50 per hourwork hours: 9 to 5education: Associate responsibilities:Access and collect information directly from various systems such as Agile PLM, SAP, Planview, and other database systems.Request, collect and organize project and technical information from various functional teams, such as operations, finance, marketing, quality, engineering, regulatory. Coordinate/lead preparation and modification, submission, and workflow approval of documentation package(s).Review documents/files submitted for initiation and/or corrections to standardize format, proofread for errors and clarity. Coordinate any modifications accordingly using appropriate engineering database systems.Edit business procedures and templates for formatting, grammar, and consistency.Assist the project lead with preparation, analysis and formatting/presentation of data required for cross-functional review. Data sets include but not limited to technical data, quality data, sales volumes, etc.Provide various project-level support for the R&D department projects, such as Change Management support, project documentation, technical reviews, meeting minutes and data analysis.As required, travel to on-site technical product reviews, process improvement or product idea brainstorming events. Coordinate/lead meeting sessions or group exercises. Support the planning and coordination of meeting logistics, both prior to the event and on-site as required.Document, organize and present meeting event results and action items. Assist in coordination of follow-up reviews of the results with the various cross functional teams. qualifications:Associates or bachelor's degree required in biomedical, mechanical, electrical or related engineering field.5 years of project management or technical project experience preferredExperience within a healthcare products, medical device or pharmaceutical company preferredAdvanced proficiency in MS Office ToolsStrong organizational and analytical skillsClear verbal and written communication, ability to work cross-functionally with a variety of audiences skills: Biomedical Engineering, Medical Device Product DevelopmentEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:The Project Support Specialist on the Global Strategic Research & Development team provides support to the Concept to Commercialization team to plan, prepare and execute technical documentation and project activities. Responsible for the creation and compliance of business process documentation in the PLM system. Assist in the planning and execution of projects under the direction of the project or technical lead. location: Wayne, Pennsylvaniajob type: Contractsalary: $30.00 - 32.50 per hourwork hours: 9 to 5education: Associate responsibilities:Access and collect information directly from various systems such as Agile PLM, SAP, Planview, and other database systems.Request, collect and organize project and technical information from various functional teams, such as operations, finance, marketing, quality, engineering, regulatory. Coordinate/lead preparation and modification, submission, and workflow approval of documentation package(s).Review documents/files submitted for initiation and/or corrections to standardize format, proofread for errors and clarity. Coordinate any modifications accordingly using appropriate engineering database systems.Edit business procedures and templates for formatting, grammar, and consistency.Assist the project lead with preparation, analysis and formatting/presentation of data required for cross-functional review. Data sets include but not limited to technical data, quality data, sales volumes, etc.Provide various project-level support for the R&D department projects, such as Change Management support, project documentation, technical reviews, meeting minutes and data analysis.As required, travel to on-site technical product reviews, process improvement or product idea brainstorming events. Coordinate/lead meeting sessions or group exercises. Support the planning and coordination of meeting logistics, both prior to the event and on-site as required.Document, organize and present meeting event results and action items. Assist in coordination of follow-up reviews of the results with the various cross functional teams. qualifications:Associates or bachelor's degree required in biomedical, mechanical, electrical or related engineering field.5 years of project management or technical project experience preferredExperience within a healthcare products, medical device or pharmaceutical company preferredAdvanced proficiency in MS Office ToolsStrong organizational and analytical skillsClear verbal and written communication, ability to work cross-functionally with a variety of audiences skills: Biomedical Engineering, Medical Device Product DevelopmentEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • san diego, california
    • contract
    • US$28.00 - US$33.00, per hour, $28 - 33 per hour
    • 8 to 4
    job summary:Looking for experienced individuals to participate on a larger team tasked with the sustainability, improvement, design, development and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomes. location: San Diego, Californiajob type: Contractsalary: $28 - 33 per hourwork hours: 8 to 4education: Bachelors responsibilities:Participate in process sustaining, definition and improvement, design, development and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomesTroubleshoot production line issues related to yield, quality and throughputConstruct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goalsAnalyze process test results, issue reports and make technical recommendationsWork cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing productsRepresent Operations needs on development teamsDefine technical requirements and write procedures for Production to process productWork on teams to develop and transfer new processes/products to production and enhance their robustness qualifications:Work experience in the biotech, pharmaceutical or semiconductor industries is desirableHigh level problem solving and reasoning skills requiredExperience with chemical processes (preferably organic) preferredExperience with statistics, Statistical Process Control and DOE techniques is a plusExperience with high volume production in a high tech, high volume consumables industry is a plusHigh level computer skills are required. Intermediate level programming knowledge is strongly desiredExperience with product development processes and project management is a plusGood interdepartmental communication skills and documentation skills are requiredDemonstrated ability to accomplish goals while working across departments is required skills: GMP (Good Manufacturing Practice), Process EngineeringEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
    job summary:Looking for experienced individuals to participate on a larger team tasked with the sustainability, improvement, design, development and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomes. location: San Diego, Californiajob type: Contractsalary: $28 - 33 per hourwork hours: 8 to 4education: Bachelors responsibilities:Participate in process sustaining, definition and improvement, design, development and quality test activities in the making of consumable products or support of processes/equipment used to sequence genomesTroubleshoot production line issues related to yield, quality and throughputConstruct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goalsAnalyze process test results, issue reports and make technical recommendationsWork cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing productsRepresent Operations needs on development teamsDefine technical requirements and write procedures for Production to process productWork on teams to develop and transfer new processes/products to production and enhance their robustness qualifications:Work experience in the biotech, pharmaceutical or semiconductor industries is desirableHigh level problem solving and reasoning skills requiredExperience with chemical processes (preferably organic) preferredExperience with statistics, Statistical Process Control and DOE techniques is a plusExperience with high volume production in a high tech, high volume consumables industry is a plusHigh level computer skills are required. Intermediate level programming knowledge is strongly desiredExperience with product development processes and project management is a plusGood interdepartmental communication skills and documentation skills are requiredDemonstrated ability to accomplish goals while working across departments is required skills: GMP (Good Manufacturing Practice), Process EngineeringEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
    • norwood, massachusetts
    • permanent
    • US$130,000 - US$140,000, per year, $130k - 140k per year
    • 7 to 3
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! location: Norwood, Massachusettsjob type: Permanentsalary: $130,000 - 140,000 per yearwork hours: 7 to 3education: Bachelors responsibilities:Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory/pilot scale process development and leading mRNA formulation process technology transfers to internal and external GMP manufacturing facilities (domestic and international). Our team's goal is to define and implement robust commercial-scale manufacturing processes. This Senior Engineer role requires close working relationships with Analytical, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.We are establishing novel processes that require a solid practical foundation in standard bioprocess unit operations ( e.g. batch and/or single-pass TFF, normal flow filtration, mixing systems, chromatography). These skills should be complemented with a track record of effective troubleshooting, excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development accomplishments using QbD-principles and PAT with feedback control are strong pluses.In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support technology transfer activities, including Person-in-Plant (PiP) support for Engineering and GMP batches in US and EU.Success in this role would be demonstrated by the implementation of robust scaled-up GMP processes and the delivery of released early- and late-phase bulk clinical supplies. This position bears the potential for significant growth in a dynamic organization.Here's What You'll Do:Develop robust, scalable and well-characterized processes for the formulation of mRNA in lipid nanoparticles. Manage and execute transfer of mRNA formulation processes from process development labs to internal and external (CMO) GMP facilities to ensure timely GMP manufacture of clinical supply materials.Serve as SME Person-in-Plant for CMO manufacturing and support process-related troubleshooting. Employ industry-standard root cause analysis methodologies, as needed.Perform GMP activities with adherence to Quality Management System requirements.Prioritize work across many process development and manufacturing initiatives.Mentor junior team members. Supervisory role may be included.Communicate clearly with program stakeholders, technical staff and external CMO partners.Ensure high quality source documentation is generated to support regulatory filings.  qualifications:Here's What You'll Bring to the Table:BS with a minimum of 8 years, or MS with a minimum of 5 years, of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.Demonstrable evidence of transferring established processes to internal or external partners.Ability to effectively document and communicate results.Experience in large molecule process development (late phase-preferred).Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.Experience in independent project management.Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations. skills: Project Management, Quality control, SOP, FDA, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! location: Norwood, Massachusettsjob type: Permanentsalary: $130,000 - 140,000 per yearwork hours: 7 to 3education: Bachelors responsibilities:Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory/pilot scale process development and leading mRNA formulation process technology transfers to internal and external GMP manufacturing facilities (domestic and international). Our team's goal is to define and implement robust commercial-scale manufacturing processes. This Senior Engineer role requires close working relationships with Analytical, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.We are establishing novel processes that require a solid practical foundation in standard bioprocess unit operations ( e.g. batch and/or single-pass TFF, normal flow filtration, mixing systems, chromatography). These skills should be complemented with a track record of effective troubleshooting, excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development accomplishments using QbD-principles and PAT with feedback control are strong pluses.In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support technology transfer activities, including Person-in-Plant (PiP) support for Engineering and GMP batches in US and EU.Success in this role would be demonstrated by the implementation of robust scaled-up GMP processes and the delivery of released early- and late-phase bulk clinical supplies. This position bears the potential for significant growth in a dynamic organization.Here's What You'll Do:Develop robust, scalable and well-characterized processes for the formulation of mRNA in lipid nanoparticles. Manage and execute transfer of mRNA formulation processes from process development labs to internal and external (CMO) GMP facilities to ensure timely GMP manufacture of clinical supply materials.Serve as SME Person-in-Plant for CMO manufacturing and support process-related troubleshooting. Employ industry-standard root cause analysis methodologies, as needed.Perform GMP activities with adherence to Quality Management System requirements.Prioritize work across many process development and manufacturing initiatives.Mentor junior team members. Supervisory role may be included.Communicate clearly with program stakeholders, technical staff and external CMO partners.Ensure high quality source documentation is generated to support regulatory filings.  qualifications:Here's What You'll Bring to the Table:BS with a minimum of 8 years, or MS with a minimum of 5 years, of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.Demonstrable evidence of transferring established processes to internal or external partners.Ability to effectively document and communicate results.Experience in large molecule process development (late phase-preferred).Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.Experience in independent project management.Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations. skills: Project Management, Quality control, SOP, FDA, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • chandler, arizona
    • permanent
    • US$75,000 - US$80,000, per year, $75k - 80k per year
    • 9 to 5
    job summary:Position: Field Service Engineer The Field Service Engineer will be responsible for performing installations, preventative maintenance and remedial repair maintenance on complex electro-mechanical semiconductor capital equipment at global customer locations. location: Chandler, Arizonajob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Perform installations, preventative maintenance and remedial repair maintenance on complex electro-mechanical semiconductor capital equipment at global customer locations.Create and maintain a high level of customer satisfaction through advanced customer service skills, implementing fast quality responses to both internal and external customers while maintaining a safety first mentality.Develop action plans for problem resolution and present to internal and external customers.Develop improvements for processes, hardware and software for continuous improvement of company's equipment / business operation.Complete detailed Field Service Reports and submit to management in a timely manner.Document issues that cannot immediately be resolved at customer site by using appropriate format.Additional duties as assigned. qualifications:5 + years field service/customer support experience of sophisticated, complex precision equipment.Bachelor's degree in chemical engineering, electrical / electronic mechanical engineering.Must possess basic troubleshooting techniques in repairing complex microprocessor controlled electro-mechanical systems.Well-able to read and interpret electronic/electro-mechanical schematics and drawings.Outstanding and extremely professional customer service skills.Ability to work with hand tools.Knowledge in any of the following areas is a PLUS: Experience working in a FAB facility, closed loop communications control, electro-mechanical controls or microprocessor based controllers, chemical handling including acids, FAB safely requirements or practices.Military experience is also a plus.International and domestic travel required. skills: Design Engineering, Electrical Engineering, Process EngineeringEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:Position: Field Service Engineer The Field Service Engineer will be responsible for performing installations, preventative maintenance and remedial repair maintenance on complex electro-mechanical semiconductor capital equipment at global customer locations. location: Chandler, Arizonajob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Perform installations, preventative maintenance and remedial repair maintenance on complex electro-mechanical semiconductor capital equipment at global customer locations.Create and maintain a high level of customer satisfaction through advanced customer service skills, implementing fast quality responses to both internal and external customers while maintaining a safety first mentality.Develop action plans for problem resolution and present to internal and external customers.Develop improvements for processes, hardware and software for continuous improvement of company's equipment / business operation.Complete detailed Field Service Reports and submit to management in a timely manner.Document issues that cannot immediately be resolved at customer site by using appropriate format.Additional duties as assigned. qualifications:5 + years field service/customer support experience of sophisticated, complex precision equipment.Bachelor's degree in chemical engineering, electrical / electronic mechanical engineering.Must possess basic troubleshooting techniques in repairing complex microprocessor controlled electro-mechanical systems.Well-able to read and interpret electronic/electro-mechanical schematics and drawings.Outstanding and extremely professional customer service skills.Ability to work with hand tools.Knowledge in any of the following areas is a PLUS: Experience working in a FAB facility, closed loop communications control, electro-mechanical controls or microprocessor based controllers, chemical handling including acids, FAB safely requirements or practices.Military experience is also a plus.International and domestic travel required. skills: Design Engineering, Electrical Engineering, Process EngineeringEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • scottsdale, arizona
    • permanent
    • US$95,000 - US$100,000, per year, $95k - 100k per year
    • 9 to 5
    job summary:The Sr. R&D Systems Engineer will support design and development activities of medical devices for proprietary products under development at the R&D site. This role has frequent interaction with R&D Engineering, Product Sustainment Engineering, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables. The individual will bring excellent analytical, engineering, and organizational talent to the execution of development projects. location: Scottsdale, Arizonajob type: Permanentsalary: $95,000 - 100,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Lead, implement and execute system engineering tools and processes within the R&D group.Lead design control process of combination products throughout product life cycle in accordance with relevant standards and FDA guidance.Participate in cross-functional teams for defining system design and performance requirements specifications while applying in-depth knowledge of design control of combination products.Mentor and guide younger system engineers.Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.Oversee risk management activities using tools such as FMEA and risk summary reports.Oversee and document design inputs and linkage between the marketing requirements, standards review, risk management, user requirements and technical requirements.Oversee and execute the documentation of design outputs and show traceability to design inputs with trace matrix (Product Requirement Matrix). Responsible for assuring all design control process and documents follow the QMS.Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct necessary training for R&D staff as methodology is established.Lead engineering and general design review as required. qualifications:At least 3-5 years of experience in design control in the medical industry.Proven experience in risk management.Education: Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.Must have excellent communication skills. Must have interpersonal skills.PREFERRED Background in R&D of Combination product.Background in R&D of electromechanical medical device.Knowledge of ISO-11608, IEC-60601, IEC-62304 is an advantage skills: Medical Device Product DevelopmentEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:The Sr. R&D Systems Engineer will support design and development activities of medical devices for proprietary products under development at the R&D site. This role has frequent interaction with R&D Engineering, Product Sustainment Engineering, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables. The individual will bring excellent analytical, engineering, and organizational talent to the execution of development projects. location: Scottsdale, Arizonajob type: Permanentsalary: $95,000 - 100,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Lead, implement and execute system engineering tools and processes within the R&D group.Lead design control process of combination products throughout product life cycle in accordance with relevant standards and FDA guidance.Participate in cross-functional teams for defining system design and performance requirements specifications while applying in-depth knowledge of design control of combination products.Mentor and guide younger system engineers.Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.Oversee risk management activities using tools such as FMEA and risk summary reports.Oversee and document design inputs and linkage between the marketing requirements, standards review, risk management, user requirements and technical requirements.Oversee and execute the documentation of design outputs and show traceability to design inputs with trace matrix (Product Requirement Matrix). Responsible for assuring all design control process and documents follow the QMS.Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct necessary training for R&D staff as methodology is established.Lead engineering and general design review as required. qualifications:At least 3-5 years of experience in design control in the medical industry.Proven experience in risk management.Education: Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.Must have excellent communication skills. Must have interpersonal skills.PREFERRED Background in R&D of Combination product.Background in R&D of electromechanical medical device.Knowledge of ISO-11608, IEC-60601, IEC-62304 is an advantage skills: Medical Device Product DevelopmentEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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