Pharmaceutical & Biotechnology
Validation Engineer
- Contract
- Cork, County Cork, Ireland
- 41996617
PE Global is currently recruiting for a Technical Operations Engineer for a leading multi-national BioPharma client based in Cork.
This is an initial 12 month contract position.
The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on
- New Product Introduction (NPI) / Life Cycle Management (LCM)
- Validation
- Process improvements
- Standards and new technology deployment
The Technical Operations Engineer is expected to continuously focus on safety, quality, GMP and operational discipline. The Technical Operations Engineer / Scientist will report solid line to the Site TO Lead or Site TO Mgr/Director – depending on the site TO structure on the site. The Technical Operations Engineer is responsible for the management and/or execution of the Validation Master Plan(s), including but not limited to process validation, cleaning validation and sterilization validation.
The Technical Operations Engineer is a key contributor to NPI / LCM and process improvement initiatives on the site. The level of contribution in the area of validation, NPI/LCM and process improvement initiatives is dependent on the education and/or experience level of the engineer.
Duties of the role/Responsibilities
- Contribute to LCM / New Product Introduction for the Site
- Manage / execute the validation program related to LCM / NPI such as process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
- Issue / review validation plan, protocols and reports
- Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
- Be the site TO representative in LCM/NPI project teams as process / validation SME
- Overall coordination of LCM projects on site, under responsibility of global TO organization
- Change control Management Technology & product technical life cycle management
- Manage / execute the annual site Validation Master Plan(s) in the area of process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
- Issue / review validation plans, protocols and reports
- Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
- Review / approve annual product reviews (APR)
- Own / lead or participate in the CPV (continued process verification) program by issuing plans, protocols and reports and oversee the execution.
- Lead complex investigations on the site by providing technical expertise (process, cleaning, aseptic, …
- Provides process / technology input to SOPs, Master Batch Records and change controls
- Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
Education/Experience
- Degree in Science or Engineering is required.
- 5 years Industry relevant experience
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on +353 21 4297900 or alternatively send an up to date CV to chloe.slingsby@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***
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