Sr Validation Engineer
Ireland – Dublin
Senior Validation Engineer (Sterilization) – Level 5
The Validation department performs equipment, utility, facility, cleaning, sterilization and transport validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
The activities of the Senior Validation Engineer are to:
- Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process.
- Development and approval of Validation Plans, IV/FTs, QRAES, IOQ’s, RQ’s, PQ’s etc. for the Vial and Syringe sterilization, formulation and utility areas in line with GMP’s, regulatory requirements and corporate standards.
- Liaise with internal clients such as Manufacturing, QC, Engineering, Commissioning and Qualification, in addition to external vendors and suppliers regarding equipment consumables, external acceptance tests (FATS/URS) to ensure the quality by design principles are being followed.
- Manage the equipment validation requalification program in line with the site validation masterplan and support NPI and other lifecycle projects where necessary
- Collate and report on relevant Validation Data and Metrics.
- Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations. In addition, provide input and guidance into multisite and local procedural requirements.
- Coordinate projects and prioritize workload in line with site priorities.
- Lead sterilization qualification projects associated with the manufacturing areas at ADL.
- Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team.
- Own, update and maintain Standard Operating Procedures (SOP’s) in accordance with site and corporate requirements.
- Participate in regulatory inspections, regulatory filings and RTQ’s.
- Attend and contribute to staff meetings and attend appropriate training sessions, as required.
- Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
- Bachelor of Science/Engineering degree or equivalent
- Knowledge of cGMP’s and other worldwide regulatory requirements
- Problem solving ability and excellent oral and written communications skills
- 8+ years’ experience in a similar role
- In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
- In depth experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
- Previous regulatory experience with regard to representing the site validation program in addition to supporting NPI regulatory marketing applications.
- Customer service
- Honesty and consistency
- Planning and prioritisation
- Drive for results
- Creative and analytical thinking
- Focus on quality
- Attention to detail
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