What are the responsibilities and job description for the Engineering Technical Lead - Packaging Lines 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 & Engineering Group, a Pinnaql company, is seeking an Engineering Technical Lead - Packaging Lines to support a 6 month contract with a key client in Thousand Oaks, CA.
Key Responsibilities:
Project Leadership & Delivery
- Serve as the primary technical lead for all packaging line engineering activities across capital projects and site initiatives.
- Oversee URS/BOD/Design Review development for vial, syringe, and/or combination-product packaging lines (e.g., filling, labeling, cartoning, serialization, aggregation, palletizing).
- Coordinate vendor selection, FAT/SAT, IOQ/PQ readiness, and integration with upstream manufacturing, utilities, and warehouse systems.
- Ensure packaging equipment design and installation comply with cGMP, GAMP 5, corporate engineering standards, and safety/ergonomic guidelines.
Commissioning & Qualification
- Lead cross-functional teams to execute Cx/Qx protocols for equipment, utilities, and automated control systems, ensuring full 21 CFR Part 11 compliance.
- Support resolution of punch-list items, deviations, and CAPAs during start-up and ramp-up phases.
- Oversee the development of SOPs, maintenance plans, and spare-parts strategies for packaging assets.
Technical Support & Continuous Improvement
- Provide technical troubleshooting for equipment reliability, product quality, and automation interfaces (e.g., SCADA/Client/MES, serialization systems).
- Drive OEE improvements, line balancing, and changeover optimization to support high-volume biotech packaging operations.
- Champion sustainability and energy-efficient design of packaging areas, aligned with LEED v4 energy & atmosphere credits.
- Ensure robust data integrity, safety, and regulatory compliance throughout the equipment lifecycle.
Team & Stakeholder Engagement
- Act as the primary liaison among Engineering, Validation, Automation, EHS, Quality, Manufacturing, and external suppliers.
- Mentor junior engineers and collaborate with Cx Agents/Consultants, Validation Leads, and Reliability teams to ensure knowledge transfer and operational readiness.
- Communicate project updates, risk assessments, and mitigation plans to site and global leadership.
Qualifications:
Required:
- Bachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).
- 8 years of engineering experience in pharmaceutical/biotech packaging lines, including installation and startup of automated filling, labeling, and cartoning equipment.
- Strong knowledge of GMP, FDA/EMA regulations, ISO 13485 (for combination products), serialization/aggregation, and GAMP 5 automation standards.
- Demonstrated success leading multidisciplinary project teams through design, construction, and qualification phases.
- Proficiency in MS Project/Primavera, technical drawing review (AutoCAD/Revit), and common plant utilities.
Preferred:
- Familiarity with Client/MES/serialization platforms (e.g., Client-X, Rockwell, Siemens, Systech, Antares).
- Excellent problem-solving, communication, and vendor-management skills.
- Lean Six Sigma Green Belt or equivalent continuous improvement training.
Core Competencies:
- Technical Leadership & Decision-Making
- GMP Compliance & Documentation Rigor
- Cross-Functional Teamwork & Vendor Coordination
- Problem Solving under Tight Timelines
- Commitment to Safety, Quality, and Sustainability
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.