What are the responsibilities and job description for the Packaging Validation Engineer position at Pinnaql?
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
Validation and Engineering Group, a Pinnaql company, is seeking a Packaging Validation Engineer with strong experience in pharmaceutical packaging systems and GMP manufacturing environments to support a biotechnology client in Allentown PA. This is a 6 month contract position with the potential for extension based on project needs and performance.
Position Overview:
We are seeking a Packaging 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.
Requirements / Skills:
- 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
Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.