Job Summary
We are seeking an experienced Senior/Lead CQV/Technical Engineer to join a cutting-edge sterile fill finish facility undergoing significant expansion. In this role, you will be instrumental in transitioning the facility from the construction phase to full commercial operation by overseeing the validation activities associated with a syringe filling line.
Key Responsibilities
* Validation Documentation: Generate, execute, review, and approve comprehensive CQV test documentation (FAT, IV, FT, SAT, and PQ) for the syringe filling line.
* Site Validation Master Plan: Contribute to the development and maintenance of the site's Validation Master Plan and Standard Operating Procedures (SOPs).
* Change Management: Manage change controls, review qualification summary reports, and generate validation summary reports.
* Risk Assessment: Support risk assessments, exception resolution, and root cause analysis.
* Team Leadership: Provide technical oversight and mentoring for a team of validation engineers, ensuring a right-first-time approach throughout commissioning, qualification, and process validation.
Ideal Candidate Profile
* Experience: Minimum 6 years' experience in Engineering or Validation within a pharmaceutical or biotechnology environment.
* Qualification: Relevant technical qualification (e.g., in Applied Pharmaceutical, Biological, Chemical sciences or Engineering).
* Regulatory Knowledge: Extensive experience executing validation activities in regulated environments, with a strong understanding of GMP and safety requirements.
* Soft Skills: Excellent communication, project management, and cross-functional collaboration skills.
* Preferred Experience: Experience with sterile/biotech equipment, cleaning and process validation, and the use of paperless qualification systems.