CSV Validation Engineer

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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