Department : Field - LL Location : Thousand Oaks, CA
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position
- Engineering Technical Lead
The Engineering Technical Lead for Packaging Lines will provide technical leadership, oversight, and subject-matter expertise for the design, installation, commissioning, qualification, and lifecycle support of packaging systems at a state-of-the-art biotechnology facility.
This role bridges project engineering, automation, validation, and operations , ensuring that packaging processes meet GMP / FDA regulatory requirements, corporate engineering standards, sustainability goals (LEED v4), and business needs for quality, cost, and schedule.
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 / BAS / 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 BAS / MES / serialization platforms (e.g., PAS-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-MakingGMP Compliance & Documentation RigorCross-Functional Teamwork & Vendor CoordinationProblem Solving under Tight TimelinesCommitment to Safety, Quality, and SustainabilitySTART YOUR APPLICATION