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LL01-251008 Engineering Technical Lead
LL01-251008 Engineering Technical LeadValidation & Engineering Group, Inc • Thousand Oaks, CA
LL01-251008 Engineering Technical Lead

LL01-251008 Engineering Technical Lead

Validation & Engineering Group, Inc • Thousand Oaks, CA
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Department : Field - LL Location : Thousand Oaks, CA

START YOUR APPLICATION

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-Making
  • GMP Compliance & Documentation Rigor
  • Cross-Functional Teamwork & Vendor Coordination
  • Problem Solving under Tight Timelines
  • Commitment to Safety, Quality, and Sustainability

    • START YOUR APPLICATION

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