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
Validation Specialist - Molding, Assembly & Metrology with strong CQV experience, particularly in injection molding, assembly processes, and metrology equipment. This is a client-facing, hands-on role requiring technical expertise, attention to detail, and the ability to work independently while collaborating across functions.
Key Responsibilities- Develop and execute validation deliverables including URS, ERES assessments, FAT/SAT protocols, IQ/OQ/PQ, POQ, and traceability matrices.
- Support qualification of molding units, assembly equipment, metrology instruments, handling systems, injection molding tools, and ISO 7 cleanrooms.
- Contribute to facility qualification activities and ensure compliance with regulatory standards.
- Assist in data handling, integration testing, and MES/SCADA system qualifications.
- Collaborate with design, manufacturing, and quality teams to ensure successful project execution.
- Prepare and maintain high-quality validation documentation.
- Provide training and technical support as needed.
Required Qualifications- Education: Bachelor's degree in engineering.
- Certifications (preferred): ISO 14971, ISO 13485, Six Sigma/Lean (Green/Black Belt), GMP training.
- Technical Knowledge:
- Injection molding equipment qualification and calibration.
- Manual and automated assembly processes (robotics, conveyors, PLCs, servo controls).
- Metrology systems, calibration, and Gage R&R.
- MES/SCADA systems in FDA-regulated environments.
- Regulatory Knowledge: 21 CFR Part 820 (FDA QSR), EU MDR 2017/745, ISO 9001, ISO 13485.
- Skills: Documentation and report writing, problem-solving, root cause analysis, cross-functional collaboration.
- Tools: Experience with Kneat software is highly desirable.
Preferred Qualifications- Experience in computerized system validation (PLC, HMI).
- Knowledge of medical device manufacturing (Class II preferred).
At
Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job; it's your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose-driven team that's as ambitious as it is supportive. 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.
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