CSV Validation Engineer job in Oxford, England

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: 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.

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