Open roleExternal
Validation Engineer
- stoke on trent, staffordshire, ST1 1AA, United Kingdom
- Hybrid
- Full time
- £58,000 - £58,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and experienced Validation Engineer to join their Quality Operations team in Stoke-on-Trent . This role is essential for ensuring that all manufacturing equipment, processes, and facilities meet stringent regulatory standards and operate consistently to produce high-quality pharmaceuticals. You will be responsible for developing and executing validation plans and protocols for a range of systems. The position requires a thorough understanding of validation principles, GMP guidelines, and documentation practices, contributing to the overall compliance and integrity of manufacturing operations in Stoke-on-Trent .
Key Responsibilities
- Develop, review, and execute validation protocols for equipment, processes, cleaning, and computer systems (IQ/OQ/PQ).
- Write comprehensive validation reports, ensuring all test results and deviations are thoroughly documented.
- Ensure all validation activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
- Collaborate with engineering, manufacturing, and quality assurance departments to ensure smooth execution of validation projects.
- Identify and address any deviations or out-of-specification results encountered during validation studies.
- Maintain validation documentation and support regulatory inspections and audits.
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, Chemical) or a related scientific field.
- Minimum of 3 years of experience in validation engineering within the pharmaceutical, biotechnology, or medical device industry.
- Strong understanding of validation principles, GMP, GAMP, and FDA/EMA regulatory requirements.
- Proven experience in developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Excellent technical writing, documentation, and communication skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and skill development.
- Pension scheme and life assurance.
- Generous holiday allowance.
- Supportive work environment with hybrid working flexibility, based near Stoke-on-Trent .
- Access to modern validation tools and technologies.