Packaging Validation Engineer_PA
2 weeks ago
We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:
- Packaging Validation Engineer
We are seeking a Validation Engineer with strong experience in pharmaceutical packaging systems and GMP manufacturing environments. The selected candidate will focus on the qualification of packaging equipment and processes, ensuring compliance with regulatory requirements and company standards. This role will support validation, packaging engineering, and continuous improvement initiatives to maintain and enhance product quality and operational efficiency.
Responsibilities:
- Lead and execute equipment and process qualification activities (IQ/OQ/PQ) for primary and secondary packaging systems, including serialization/aggregation systems.
- Prepare and execute validation protocols and reports, ensuring adherence to cGMP, FDA, and EU regulatory expectations.
- Support packaging validation life-cycle documentation, including URS, FRS, DS, FAT, SAT, risk assessments, and traceability matrices.
- Participate in deviations, CAPAs, and change control processes related to packaging systems and associated utilities.
- Collaborate with Production, Engineering, and Quality to troubleshoot equipment and process issues during qualification and routine operations.
- Support technology transfer activities and new product introductions related to packaging operations.
- Coordinate multiple project tasks from inception to completion, applying sound project management and documentation practices.
- Ensure compliance with GMPs, Good Engineering Practices (GEP), and company standards and procedures.
- Bachelor of Science degree in Engineering (Mechanical, Packaging, Chemical, or related discipline) or in Natural Sciences.
- 5+ years of experience in pharmaceutical, medical device, or biotech environments, with a focus on equipment qualification and packaging systems.
- Solid knowledge of primary and secondary packaging equipment and materials (vials, syringes, bottles, labels, cartons, etc.).
- Strong understanding of validation principles, including IQ/OQ/PQ, risk assessments, and validation life-cycle documentation.
- Experience developing and executing technical documents (URS, FRS, DS, FAT/SAT, protocols, and reports).
- Familiarity with serialization and aggregation systems (Optel) preferred.
- Excellent analytical, organizational, and technical writing skills.
- Strong communication skills (written and verbal) with ability to interface effectively with cross-functional teams and clients.
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