LLEngineering Technical Lead

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 areas of 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.

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Strategy/Planning and Information Technology