Validation Specialist

The role:
PE Global is currently recruiting for a QA Validation Specialist on behalf of our client based in Dublin. This is an initial 12 month contract role.

Responsibilities:

• Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance manufacturing facility at Alexion College Park Dublin.
• Develop and implement/update cleaning strategies for fixed and mobile parts.
• Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
• Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required.
• Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
• Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
• Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.

Qualifications

• 1 – 3 Years of Experience
• Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.

Interested candidates should submit an updated CV.
 
Please click the link below to apply, call William on 0214297900 or alternatively send an up to date CV to william.cunnage@peglobal.net
 
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***