Validation Engineer
Validation Engineer
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Job Description
Catalents Swindon facility houses our Zydis fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability.
Catalent are currently recruiting for a Validation Engineer to join the Swindon site. The Validation engineer will work as part of the Validation team on the Pharmaceutical Validation processes to ensure that the business Products Equipment Computer systems and cleaning processes are qualified and remain in control.
The role:
- Complete data analysis and review of commercial products to ensure Continuation of Validated Processes through Continuous Process Verification (CPV) which contribute to Quality Annual Product Reviews (APRs).
- Write basic strategy documents for Process Validation activities Protocols and subsequent Reports for Process Validation activities write Validation Plans protocols complete SIAs and DIAs and execute computer system validation activities.
- Complete Cleaning Validation assessments writes CV protocols and Summary Reports
- Participates in Equipment Validations e.g. Routine Temperature Mappings (Fridges/Freezers Freeze Tunnels Stability facilities Incubators and Warehouse)
- Review URSs and write Validation Plans FATs SATs IOPQs and execute Equipment Validation activities.
- Participate in Validation History Reviews for systems to ensure validation practices are compliant with the most up to date regulatory requirements and assess requalification requirements
- Experience with performing Deviations including Root Cause Analysis and other tools to implement appropriate CAPA. Builds and maintains employer and employees duty of care in relation to EH&S
- Participates in office safety inspections
The Candidate:
- Experience working within a Quality environment for pharmaceutical or medical devices.
- Appropriate Science based Degree or relevant industrial experience.
- Strong numeracy / literacy skills
- Confident user of Microsoft Excel & Minitab
- Experience with other quality systems such as Trackwise would be preferred
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Employment Type
Full-Time
