We are seeking an experienced Senior/Lead CQV/Technical Engineer to join our state-of-the-art sterile fill finish facility during its significant expansion phase.
Key Responsibilities
* Generating, executing, reviewing, and approving CQV test documentation (FAT, IV, FT, SAT, and PQ) for the syringe filling line.
* Contributing to the development and maintenance of the site Validation Master Plan and Standard Operating Procedures (SOPs).
* Managing change controls, reviewing qualification summary reports, and generating validation summary reports.
* Supporting risk assessments, exception resolution, and root cause analysis.
* Providing technical oversight and mentoring for a team of validation engineers, ensuring a right-first-time approach throughout commissioning, qualification, and process validation.
Requirements
* A minimum of 6 years' experience in Engineering or Validation within a pharmaceutical or biotechnology environment.
* A relevant technical qualification (e.g., in Applied Pharmaceutical, Biological, Chemical sciences or Engineering).
* Extensive experience executing validation activities in regulated environments, with a strong understanding of GMP and safety requirements.
* Excellent communication, project management, and cross-functional collaboration skills.
* Preferably, experience with sterile/biotech equipment, cleaning and process validation, and the use of paperless qualification systems.