- 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.
- 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.
CSV Consultant - Oxfordshire, United Kingdom - Proclinical Staffing
Description
Job Description
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:
Key Skills and Requirements:
If you are having difficulty in applying or if you have any questions, please contact Will Hitchcock at
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.
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