Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
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.
DESCRIPTION:
Reporting to the Senior Manager of Engineering, this position leads the Manufacturing Support Engineering (MSE) team in providing 24/7 manufacturing equipment support. The manager maintains equipment readiness through preventive maintenance (PM), work notifications, troubleshooting, and improvements, including associated automation and infrastructure. The role balances urgent production needs with planned maintenance and sustained reliability while protecting safety, product quality, and cGMP compliance. The manager develops team capability, coordinates resources across shifts, and partners with Manufacturing, Quality, Automation, and Capital Engineering on equipment qualification and new capabilities. Improvements use failure risk management, Practical Process Improvement (PPI), and sound engineering principles. All MSE activities follow EH&S requirements, site SOPs, and site and corporate standards.
What will you do?
- Lead MSE staffing, shift handoffs, and escalation processes to provide consistent equipment support across all shifts, weekends, and holidays.
- Manage PM planning, scheduling, execution, and closure. Coordinate equipment access and assess overdue maintenance and deferrals through approved procedures.
- Own work notifications from assessment through execution, documentation, and closure. Prioritize work by safety, quality, equipment criticality, and production impact.
- Guide troubleshooting and repairs, coordinate specialists and vendors, and verify required checks and approvals before equipment returns to service.
- Allocate resources across breakdowns, planned maintenance, and improvements. Review backlog and aging work regularly to address unresolved risks.
- Communicate equipment status, recovery plans, and risks to Manufacturing, site leadership, and clients. Lead escalation during significant equipment events.
- Support equipment selection, installation, commissioning, and qualification with Capital Engineering. Establish maintenance plans, documentation, spare parts, and training before handover.
- Apply PPI, lean methods, failure trend analysis, and root cause analysis to improve equipment reliability and prevent repeat failures.
- Track PM completion, work backlog and aging, downtime, repeat failures, and improvement results to guide team priorities.
- Maintain accurate maintenance history, controlled procedures, and technical records. Provide equipment documentation and technical explanations for audits and inspections.
- Support deviations, investigations, corrective and preventive actions, and change control with Quality. Assess maintenance, qualification, and automation impacts.
- Coach team members, manage performance, and maintain training and technical coverage across shifts. Coordinate spare parts and external service support.
- Ensure safe work practices, timely documentation, and compliance with EH&S requirements, site SOPs, and cGMP expectations.
Qualifications
- Bachelor’s degree in an engineering discipline, or equivalent relevant experience.
- 8+ years of experience in a GMP environment.
- 5+ years supporting pharmaceutical equipment maintenance and manufacturing, included within the overall GMP experience requirement.
- 2+ years of supervisory experience preferred.
- Proficiency with maintenance or work management systems and Microsoft Office.
- Strong knowledge of cGMP requirements and controlled documentation practices.
Experience
- Experience troubleshooting manufacturing equipment, managing preventive maintenance, and improving equipment reliability.
- Experience with equipment qualification, technical documentation, and associated automation systems.
- Experience assessing equipment, system, automation, and process changes through controlled change management.
Knowledge, Skills, Abilities
- Sound judgment when resolving equipment failures while protecting safety, product quality, and compliance.
- Ability to build effective relationships with Manufacturing, Quality, Automation, Capital Engineering, service providers, and clients.
- Effective coaching and leadership skills, including developing technical capability, managing performance, and leading change.
- Clear written, verbal, and presentation skills, including explaining technical risks to site leadership.
- Ability to prioritize competing demands and allocate resources in a 24/7 manufacturing environment.
- Ability to use equipment history and work management data to identify recurring failures and measure improvements.
- Strong problem-solving skills and the ability to coordinate technical specialists across multiple equipment issues and projects.
