LL01-251008 Engineering 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 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