validation specialist - sterilisation validation (sip) in borehamwood

posted
job type
permanent
salary
£ 40,000 per year
apply now

job details

posted
location
borehamwood, hertfordshire
job category
pharmaceutical
job type
permanent
salary
£ 40,000 per year
reference number
VS_SV
phone
0208 957 2606
apply now

job description

Roles : Validation Specialist - Sterilisation Validation (SIP)

Hours : 9-5

Pay : £40k - £55k + Up to £2k pa Bonus

Benefits : 25 days holiday + Bank Holiday, Pension up to 6% Matched , life assurance , free parking

Location : BPL, Dagger Lane, WD6 3BX

BPL is based in Elstree, Hertfordshire the enclosed secure campus is surrounded in natural beauty, greenery, lakes and wildlife. A truly wonderful working environment, along with an extremely supportive team.

Working within a niche sector within the pharmaceutical industry, this opportunity will give the successful candidate a chance to develop themselves and learn new skills that could see them enjoy a highly successful career.

BPL has a significant annual and longer-term investment plan to optimise existing production and processes, and dramatically increase production capacity over the next 3-5 years , the Validation team form a key part of this programme.

Roles and Responsibilities :

As part of the Validation team, you will be taking ownership of all aspects of service delivery which relate to equipment commissioning, qualification and validation within your remit. You will be ensuring compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. You will need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.

Essential Skills :



* Must have worked within a in Sterilisation Validation (SIP)
* In depth knowledge of the requirements of EN285 and its practical application when validating porous load sterilisers.
* In depth knowledge of the requirements and expectations associated with depyrogenation validation.
* In depth knowledge of the requirements and expectations associated with Hydrogen Peroxide biodecontamination.
* Fully conversant in the requirement and expectations around cycle/load development and worst case challenging of sterilisation/depyrogenation/biodecontamination processes.
* Practical hands-on experience of executing sterilisation/depyrogenation/biodecontamination validations.
* You understand, can clearly explain and would be able to train others sterilisation/depyrogenation/biodecontamination validation.
* Collective responsibility for the ongoing compliance of all assets at the Elstree, Hertfordshire facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
* Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
* Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
* Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.

Please apply today or call Ben on 02089572606 for more information

skills

validation, environment, gmp, gdp, pharma, blood, plasma, EN285 , EHS, GxP, Quality, depyrogenation, biodecontamination