Director, Engineering & Facilities – Biotech Manufacturing

Location: On-site – Piscataway, New Jersey (Relocation assistance available)

Global Life Science Hub is supporting a rapidly growing US-based biopharmaceutical manufacturer in the search for a Director of Engineering & Facilities. This organisation has recently secured two FDA approvals, with a third on the horizon, and is scaling significantly—from 50L to 2,000L bioreactor capacity—as they expand their biologics and sterile manufacturing capabilities.

This is a key leadership position, responsible for overseeing all engineering functions supporting biotech operations at their New Jersey site. The role plays a critical part in capital project execution, equipment and facility readiness, compliance, and operational excellence.

Key Responsibilities:

• Lead all site engineering and facility-related functions across biologics manufacturing and aseptic fill-finish operations
• Plan and manage engineering strategies, capital investments, and equipment installation projects in alignment with cGMP, FDA, and local regulations
• Oversee facility qualification, utilities, calibration, and maintenance programs across the plant
• Support scale-up and tech transfer activities, ensuring timely and compliant execution of new capabilities
• Supervise and develop multidisciplinary teams including maintenance, reliability, and project engineering personnel
• Collaborate with external contractors and internal leadership to deliver complex engineering projects on time and within budget
• Maintain audit readiness and ensure robust engineering documentation, SOPs, and preventive maintenance programs
• Provide cross-functional leadership, contributing to site-level strategy, continuous improvement, and compliance initiatives

Requirements:

• Bachelor’s degree in Mechanical, Chemical, or related Engineering discipline (advanced degree or business certification preferred)
• 7–10 years’ experience in pharmaceutical or biotech manufacturing environments
• Strong background in capital project execution, maintenance systems, and compliance in GMP-regulated settings
• Experience in biologics, aseptic fill-finish, and sterile operations
• Proven ability to lead diverse engineering teams in a fast-paced, scaling environment
• Six Sigma, PE certification, or project management qualifications a plus
• Ability to travel internationally for tech transfer and facility support as required

This is a rare opportunity to shape the engineering function of a growing biotech site during a period of major investment and expansion. If you’re ready to step into a high-impact leadership role, get in touch with Global Life Science Hub to discuss further.