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:

• Bachelors degree in Mechanical Electrical Chemical or Industrial Engineering (Masters 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