Similar posts
CSV Validation Engineer
- Contract
- Good Manufacturing Practice (GMP)
- United Kingdom
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a dedicated CSV Validation Engineer to join our dynamic validation team. The successful candidate will play a crucial role in ensuring our biotech facility equipment, utilities, instrumentation, and computerized systems are qualified and maintained in a validated state in line with regulatory guidance. This role involves coordinating with internal teams and external contractors, managing CQV campaigns, and conducting data integrity assessments.
Responsibilities:
- Establish, revise, and maintain validation plans and procedures for equipment qualification.
- Write and execute qualification protocols and generate reports, including acceptance criteria.
- Coordinate scheduling, execution, and review of qualification protocols/reports.
- Manage vendors and contractors performing qualification activities.
- Oversee projects associated with computerized equipment and system validation (CSV).
- Conduct data integrity assessments and equipment requalification.
- Review, revise, and complete documentation in accordance with cGMP.
- Provide impact assessments for change controls and deviations related to validated status of utilities, equipment, instruments, and systems.
- Assist with troubleshooting equipment/system failures.
- Participate in project teams for design, procurement, and installation of new equipment and facility expansion projects.
- Support equipment and process-related non-conformance investigations and change control activities.
- Assist with internal and regulatory agency audits/inspections.
- Ensure training is kept in GMP compliant state.
Key Skills and Requirements:
- Bachelor's degree in a Scientific, Engineering or similar subject. A Master's degree is preferred.
- Professional experience in validation, engineering, or operations.
- Relevant experience in a cGMP environment is preferred.
- Experience with GMP utilities and equipment is preferred.
- Experience with DIA and CSV is required.
- Excellent communication and interpersonal skills.
- Attention to detail, flexibility, and technical writing skills.
- Good knowledge of cGMP & GDP requirements.
- Ability to work independently or in a team environment, self-motivated and showing initiative.
If you are having difficulty in applying or if you have any questions, please contact Will Hitchcock at w.hitchcock@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#QACompliance
Related jobs
Highly Competitive
Visp, Switzerland
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a Welding Quality Inspector. This is a temporary contract position based in Visp, Switzerland.
Highly Competitive
Bensheim (64625), Germany
Proclinical ist auf der Suche nach einem FRA /QP §15 GMP / HOMEO-Hauptquartier für eine Festanstellung.
Highly Competitive
Lexington, USA
Proclinical is working alongside a pharmaceutical company seeking a Senior QC Scientist specializing in Analytical Method Development to join their team.
Highly Competitive
Berne, Switzerland
Proclinical is currently working alongside a pharmaceutical company to recruit for a Senior Quality Engineer. This is a temporary contract position based in Bern, Switzerland.
Highly Competitive
Cambridge, USA
Proclinical is working alongside a pharmaceutical company to recruit for a Manager of Quality Assurance Operations. This is a temporary contract position based in Cambridge, Massachusetts.
Highly Competitive
Visp, Switzerland
Proclinical is seeking a CQV Engineer to join our client's team on a contract basis.
Highly Competitive
Cambridge, USA
Proclinical is working alongside a pharmaceutical company seeking a Quality Assurance Specialist to join their team.
Highly Competitive
Visp, Switzerland
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a QC Analyst. This is a temporary contract position based in Visp, Switzerland.
Highly Competitive
Basel, Switzerland
Proclinical is currently working alongside a pharmaceutical company to recruit for an Associate Scientist for Technical Development. This is a temporary contract position based in Basel.
Highly Competitive
Visp, Schweiz
Proclinical is seeking a QA Specialist to join our client's team in Visp, Switzerland. This is a contract role.