Director, Manufacturing Engineering

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 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 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
• Master’s degree in Engineering Management or MBA preferred
• Minimum of 10 years of experience in a relevant field that includes at least 2 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.

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