Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
POSITION SUMMARY
The Senior 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 Senior 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 site can achieve STRAP including infrastructure, utilities, equipment, capacity planning, resources, budgets and governance.
- 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 partner with global team to identify/develop training programs to ensure alignment between team capabilities and business needed.
- Partner with Divisional and global Engineering to ensure alignment and implementation of Engineering standard, knowledge sharing/lesson learned and participate in Engineering community of Practice to represent the site.
Qualifications:
- Bachelor’s degree in Engineering, Science or related fields required
- Master’s degree in Engineering Management or MBA preferred
- Minimum of 15 years of relevant experience, including at least 5 years of management experience
- Minimum of 5 years of pharmaceutical experience with a solid foundation in the regulatory requirements of the pharmaceutical industry
- Experience in a regulated manufacturing environment required; pharmaceutical, biotech, sterile manufacturing, GMP, or similar industry experience strongly preferred.
- Demonstrated experience leading capital project portfolios, site infrastructure planning, commissioning, start-up, turnover, and project delivery.
- Broad technical knowledge across engineering disciplines, including 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, with the ability to engage senior leaders, customers, regulatory agencies, vendors, contractors, and cross-functional partners.
- Strong operational excellence experience in SMED, RCM, OEE, Six Sigma, and Lean.
