Job Overview:
The Validation Engineer role involves ensuring the quality and integrity of equipment and instruments in aseptic fill finish facilities.
* Evaluate and assess documentation generated by vendors, including C&Q and calibration/thermal mapping documents.
* Prepare, execute, and summarize validation reports for a range of equipment and instruments, from the PQ stage onwards.
* Support and review documentation related to calibration and thermal mapping, ensuring compliance with cGMP requirements.
* Identify and evaluate validation needs, including new equipment installations, change controls, and revised processes.
* Collaborate with project managers to ensure project schedules are adhered to and that validation requirements are met.
* Develop and implement validation standards, procedures, and reports to ensure compliance with regulatory requirements.
Key Responsibilities:
1. Review and evaluate vendor-generated documentation to ensure accuracy and completeness.
2. Develop and maintain validation protocols and change controls plant-wide.
3. Assess current practices to identify areas for improvement and implement changes as needed.
4. Coordinate and approve SDLC documentation.
5. Monitor project status and provide updates as required.
Requirements:
* Strong analytical and problem-solving skills.
* Excellent communication and collaboration skills.
* Ability to work independently and as part of a team.
* Knowledge of cGMP regulations and industry standards.
Benefits:
This role offers a unique opportunity to make a meaningful contribution to the company's commitment to quality and customer satisfaction. The successful candidate will have the opportunity to work collaboratively with cross-functional teams and develop their skills and expertise in validation engineering.
Why this job?
This role is ideal for a motivated and detail-oriented individual who is passionate about ensuring the highest standards of quality and compliance. If you are looking for a challenging and rewarding career opportunity, this could be the perfect fit for you.