Director of Engineering

We are currently looking for a Director of Facilities & Engineering to join a rapidly expanding advanced biologics manufacturing organisation based in Massachusetts. This is a senior leadership opportunity for an experienced engineering and facilities professional to take ownership of a critical GMP manufacturing site, leading the facilities, engineering, maintenance, metrology, CQV, automation and infrastructure functions. Reporting to the Vice President of Operations, you will play a key role in ensuring the ongoing reliability, compliance and performance of a highly regulated manufacturing environment supporting the production of advanced therapeutics. The successful candidate will be responsible for developing engineering strategy, leading capital investment projects, supporting regulatory inspections and customer audits, and building a high-performing technical organisation capable of supporting future commercial growth. This role would suit an experienced Facilities & Engineering leader who combines strong GMP expertise with excellent people leadership skills and a proven ability to operate effectively within complex pharmaceutical, biotechnology or CDMO environments.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Director of Facilities & Engineering will be varied; however, the key duties and responsibilities are as follows: Provide strategic leadership across Facilities, Engineering, Maintenance, Metrology, CQV, Automation and Site Infrastructure functions to support manufacturing operations and business growth. Ensure the reliable operation, maintenance, calibration, qualification and validation of GMP manufacturing equipment, facilities and utilities. Lead major capital projects, facility expansions, infrastructure improvements and equipment upgrade programmes. Oversee engineering compliance activities, supporting customer audits, regulatory inspections, quality systems and change management processes. Develop, mentor and lead multidisciplinary technical teams whilst managing departmental budgets, resource allocation and long-term succession planning. Drive continuous improvement initiatives focused on reliability, operational excellence, compliance and cost efficiency. Collaborate closely with Manufacturing, Quality, Validation and other key stakeholders to support production readiness and site performance. Act as a key member of the site leadership team, contributing to strategic business planning and future growth initiatives.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Director of Facilities & Engineering, we are looking to identify the following on your profile and past history: Bachelor's Degree in Engineering or a related technical discipline. Significant leadership experience within GMP-regulated pharmaceutical, biotechnology, biologics or life sciences manufacturing environments. Demonstrated experience leading Facilities and Engineering teams, managing capital projects, supporting regulatory inspections and driving operational excellence within a manufacturing setting. Strong knowledge of GMP regulations, engineering compliance, validation, maintenance, utilities and facility management principles. Previous experience within a CDMO environment would be highly advantageous. Experience supporting biologics, advanced therapies, gene therapy, mRNA, vaccine or related manufacturing operations would be beneficial. Proven ability to lead and develop technical teams whilst influencing stakeholders across multiple business functions.

WHAT'S IN IT FOR YOU?

Joining our client means becoming part of an innovative and rapidly growing advanced therapeutics organisation operating at the forefront of biologics manufacturing. You will have the opportunity to influence site strategy, support major expansion projects, develop high-performing technical teams and play a key leadership role within a business entering an exciting phase of growth. The role offers a highly competitive compensation package, including a base salary of approximately $200,000, a 20% annual bonus and comprehensive benefits. This is an excellent opportunity for an experienced engineering leader looking to make a significant impact within a technically advanced and highly regulated manufacturing environment. Key Words: Facilities / Engineering / GMP / Biologics / CDMO / Maintenance / Validation / CQV / Capital Projects / Manufacturing / Leadership / Advanced Therapies / Biotechnology / Automation Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. #J-18808-Ljbffr Hyper Recruitment Solutions Ltd