Role Purpose
The role of this key team member within the Manufacturing Department will include responsibility for the manufacture and validation of processes for recombinant antibodies for veterinary use. This will include working with teams, both on the Offaly site and externally with Contract Manufacturing Organizations for some of the process development activity, and for technical transfer of the process into the client's facility.
Reporting Structure
Reporting to the Manufacturing Manager
Duties & Responsibilities
Job-Specific Duties may include but are not limited to:
Documentation:
- P.O. generation and ordering for manufacturing to support production batches * Assist with writing SOPs and Forms.
- Record data and log activities according to cGMP standards.
Production Activities:
- Calibration, set-up and use of production equipment including - autoclave, balances, pH and conductivity meters, osmometers, Blood Gas Analyzers and peristaltic pumps.
- Prepare solutions, including buffers, reagents, and cell culture media and related tasks including but not limited to pH titration, osmolality adjustment, sterile filtration techniques, and sampling.
- Prepare and operate equipment according to written procedures (SOPs)
- Assist with setting up the GMP areas for batch production including received materials, stock counts and performing cleaning tasks.
- Sanitization of the WFI loop
- Perform routine WFI sampling for Production.
- Log production samples to QC.
- May include cross training in additional functional areas such as inventory management services.
Accountability:
- Perform all duties with a high level of honesty and integrity and adhere to all site safety, environmental and quality policies on site.
- Based on business needs, weekend work may be required.
POSITION SPECIFICATION
Qualifications, Experience, Skills, Knowledge and Attributes
- Leaving Cert or Equivalent.
- Applicants with Higher Certificates (NFQ Level 6) or Ordinary Bachelor's degrees (NFQ Level 7) in science-related fields would be advantageous.
- GMP experience would be a distinct advantage.
- Basic use of MS office.
- All applicants must have competence in spoken and written English
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
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