Automation & Engineering Leadership

Job Description

We are seeking a senior automation and engineering leader to support complex client engagements across pharmaceutical, biotechnology, and medical device manufacturing environments.

This role is ideal for an experienced consultant or engineering leader who can operate at both the strategic and technical levels. The Principal Consultant will provide leadership across automation, process engineering, facility implementation, technology transfer, and GMP project execution. The position requires the ability to guide clients through critical manufacturing initiatives, manage cross-functional teams, and ensure programs are delivered with strong technical quality, regulatory alignment, and client confidence.

Responsibilities

• Lead complex automation, engineering, and manufacturing support programs across capital, expense, and operational improvement initiatives
• Manage project execution against defined scope, timelines, budgets, quality expectations, and regulatory requirements
• Serve as a senior technical advisor to client stakeholders across engineering, manufacturing, quality, validation, and operations
• Provide leadership for automation systems, process equipment, clean utilities, facility integration, and manufacturing infrastructure
• Support facility start-ups, expansions, technology transfers, process scale-ups, and commercial manufacturing readiness activities
• Coordinate cross-functional teams to drive alignment, resolve issues, and maintain program momentum
• Review and provide direction on engineering documentation, drawings, specifications, design packages, and technical deliverables
• Support cGMP documentation and execution activities, including change controls, investigations, commissioning, qualification, and validation deliverables
• Lead troubleshooting, system optimization, start-up support, and performance improvement efforts for manufacturing systems
• Identify project risks, communicate mitigation plans, and maintain strong client relationships throughout delivery
• Mentor junior consultants and contribute to a collaborative, high-performing consulting environment

Qualifications

• 12–15+ years of experience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
• Bachelor’s degree in Engineering required; Electrical, Computer, Chemical, Mechanical, Biomedical, or related disciplines preferred
• Master’s degree or advanced technical degree preferred
• Strong background in automation engineering, process systems, manufacturing equipment, facilities, and/or utilities
• Experience working within GAMP 5, cGMP, cGxP, and validated system environments
• Demonstrated success leading large-scale capital projects, complex technical programs, or multi-site client initiatives
• Strong understanding of commissioning, qualification, validation, and regulatory expectations in GMP manufacturing
• Experience with clean utilities such as WFI, RO/DI, clean steam, or related systems strongly preferred
• Ability to manage stakeholders, priorities, risks, timelines, and budgets in demanding client environments
• Strong communication, leadership, problem-solving, and influencing skills
• Comfortable operating as both a strategic advisor and hands-on technical leader
• Proven ability to coach, mentor, and elevate team performance

Benefits:

• Health insurance
• Vision insurance

Experience:

Label: pharmaceutical, biotechnology, medical device manufacturing: 10 years (Required)

Work Location:

In person