Syringe Filling Line (Sterile Fill-Finish Facility)
Overview
We are seeking an experienced Validation Engineer to support the validation activities for a Syringe Filling Line within a sterile fill-finish facility. The successful candidate will ensure that all validation activities are executed in compliance with GMP standards and quality requirements.
Key Responsibilities
* Generate, execute, review, and approve CQV test documentation including FAT, IVs, FTs, SATs, and PQs for the Syringe Filling Line.
* Review, pre-approve, and post-approve validation protocols.
* Contribute to site Validation Master Plans and Standard Operating Procedures (SOPs).
* Collate and report relevant validation data and metrics.
* Assist in exceptions, deviation resolution, and root cause analysis.
* Review validation planning documents detailing overall project strategy.
* Review and approve Qualification Summary Reports (QSRs).
* Generate Validation Summary Reports (VSRs).
* Support development of User Requirement Specifications (URSs) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Education & Experience
* 6+ years' experience in Engineering or Validation within the pharmaceutical/biotechnology industry.
* Technical qualification at third level (or equivalent) in Engineering or a related discipline.
* Extensive knowledge and proven experience in executing validation activities for pharmaceutical/biotech projects.
* Experience with sterile/biotech equipment in a pharmaceutical environment is highly desirable.
* Strong knowledge of GMP and safety requirements.
* Demonstrated strong communication and stakeholder management skills.
* Experience with Paperless Qualification Systems preferred.
* Solid understanding of risk-based approaches to commissioning, qualification, and validation in biotechnology.