Validation & Engineering Group Inc.
Engineering Technical Lead
Validation & Engineering Group Inc., Thousand Oaks, California, United States, 91362
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
(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