Director, Manufacturing Engineering

Work Schedule

Standard (Mon‑Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) and safety standards. Required personal protective equipment includes safety glasses, gowning, gloves, lab coat, ear plugs, etc.

Group/Division Summary

The Drug Product Division – North America (DPD‑NA) is one of five divisions within the Pharma Services Group. Approximately 4,400 colleagues across six sites specialize in taking sterile injectable and oral solid‑dose drug products from development to commercialization.

Position Summary

The Director, Engineering is a key member of the site leadership team, responsible for leading the site engineering organization—including utilities, facilities, automation, instrumentation, reliability, maintenance, capital expansion (CAPEX), and technical support. This role owns the engineering strategy, site master planning, and capital investment roadmap needed to support business growth, compliance, safety, reliability, and long‑term asset performance. The Director partners closely with site leadership, cross‑functional teams, customers, regulatory agencies, vendors, and contractors to ensure technical systems and infrastructure support current operations and future site needs.

Key Responsibilities

• Lead the site engineering organization, including utilities, facilities, automation, instrumentation, reliability, maintenance, CAPEX and technical support.
• Partner with the Site VP/GM and site leadership team to align engineering priorities with site strategy, customer commitments, compliance requirements, operational improvement and business growth.
• Own the Site Master Planning to assure the site can achieve STRAP, covering infrastructure, utilities, equipment, capacity planning, resources, budgets and governance.
• Provide direct technical support for process systems, equipment, automation, utilities, facilities, instrumentation, maintenance, reliability, and cleaning programs.
• Ensure engineering systems, programs, and projects comply with applicable SOPs, cGMPs, quality requirements, safety standards, environmental expectations, regulatory requirements, and building codes.
• Represent engineering in customer interactions, business development opportunities, proposals, regulatory inspections, audits, project updates, and site capability discussions.
• Partner with operations, quality, EHS, finance, technical services, commercial teams, procurement, vendors, contractors, and consultants to resolve complex technical issues and deliver business results.
• Build and develop a high‑performing engineering organization through clear objectives, coaching, engagement, career development, and leadership consistent with Thermo Fisher Scientific’s values.
• Develop a capability matrix for the engineering team and collaborate with the global team to identify and develop training programs that align team capabilities with business needs.
• Collaborate with divisional and global engineering to ensure alignment and implementation of engineering standards, knowledge sharing, lessons learned, and participation in the Engineering Community of Practice.

Qualifications

• Bachelor’s degree in Engineering, Science or related fields; Master’s degree in Engineering Management or MBA preferred.
• Minimum of 10 years of relevant experience, including at least 2 years of management experience.
• Minimum of 5 years of pharmaceutical experience with a solid foundation in regulatory requirements of the pharmaceutical industry.
• Experience in a regulated manufacturing environment (pharmaceutical, biotech, sterile manufacturing, GMP, or similar) strongly preferred.
• Demonstrated experience leading capital project portfolios, site infrastructure planning, commissioning, start‑up, turnover, and project delivery.
• Broad technical knowledge across engineering disciplines: mechanical, electrical, automation, civil, utilities, facilities, reliability, process systems, and manufacturing infrastructure.
• Working knowledge of cGMPs, regulatory expectations, quality systems, safety requirements, environmental standards, and building codes.
• Proven ability to lead teams, manage complex technical issues, assess risk, handle ambiguity, and make sound decisions in a fast‑paced environment.
• Strong communication, influencing, business acumen, and stakeholder management skills; ability to engage senior leaders, customers, regulatory agencies, vendors, contractors, and cross‑functional partners.
• Operational excellence experience in SMED, RCM, OEE, Six Sigma, and Lean.