Validation Specialist
3 weeks ago
Company Profile:
We are partnered with a leading pharmaceutical organization who are seeking to hire a junior Validation Engineer on an initial 12 month contract.
Interested in gaining valuable first hand experience with biopharma and enhancing your process validation resume for a global brand.
If you enjoy working in a collaborative environment and contributing to project goals please do reach out for more info.
Job Summary:
This role of CQV Engineer will be responsible for commissioning, qualification, and validation activities relating to GMP and non-GMP equipment/system types across multiple projects.
Commissioning involves testing systems prior to operations to confirm the correct installation and establishing that it's functioning as intended while complying with Good Engineering Practices and EHS requirements.
Qualification involves testing quality-impacting equipment by verifying the necessary functionality required for the end-user and is focused on Good Manufacturing Processes through documenting IQ, OQ and PQ.
Validation processes continue throughout the lifecycle by collecting ongoing performance data to ensure the validated state remains.
This position will report to the Senior Manager, Validation and will be focused on the sustaining validation element of the lifecycle, involved in delivering requalification and periodic reviews of qualified equipment and systems.
The role will be expected to adhere to schedules, execute validation testing, generate GMP documentation, provide regular updates to management, and troubleshoot and investigate issues as required.
There will also be opportunities to become involved in cleaning validation and CQV project work as the role progresses.
Key Responsibilities
• Generating and completing CQV documentation to satisfy requirements and executing test deliverables for requalification and periodic review testing as applicable.
• Adhering to deadlines as scheduled by the team leader.
• Inputting to a wider CQV team and liaising with cross-functional teams to ensure timely completion and approval of CQV deliverables.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for CQV issues.
• Ensuring adherence to governing site and global procedures and regulatory guidelines.
Qualifications & Experience
The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline.
• Previous CQV experience is an advantage, previous GMP experience is essential.
• The ideal candidate would have biopharmaceutical Process / Validation knowledge.
• Exposure to cGMP in a fast-paced environment is required.
• Previous experience in working in a drug product filling facility would be advantageous.
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