We are seeking an experienced Senior/Lead CQV/Technical Engineer to join our sterile fill finish facility undergoing significant expansion. This role is instrumental in transitioning the facility from construction phase to full commercial operation by overseeing validation activities associated with a syringe filling line.
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.