Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights
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:
As a Sr Manufacturing Engineer at Thermo Fisher Scientific, you are responsible for ensuring the reliable operation, maintenance, and lifecycle management of sterile manufacturing process equipment and clean utility systems supporting vial filling and formulation operations. This role provides technical leadership for maintenance activities, equipment reliability, continuous improvement initiatives, and capital projects while ensuring compliance with GMP, regulatory, safety, and quality requirements. Working collaboratively across Engineering, Manufacturing, Quality, Validation, and Supply Chain, the Senior Engineer drives equipment performance, minimizes downtime, and supports the successful delivery of manufacturing objectives.
Equipment Reliability & Maintenance
- Own the maintenance strategy and lifecycle management for assigned sterile manufacturing process equipment and clean utility systems.
- Lead troubleshooting, repair, and root cause investigations to improve equipment reliability and reduce unplanned downtime.
- Plan, schedule, and execute preventive and predictive maintenance activities in alignment with production requirements.
- Monitor equipment performance and implement reliability improvements to maximize equipment availability and operational efficiency.
- Support calibration and maintenance activities to ensure equipment remains in a validated state.
Technical Ownership
- Serve as the Subject Matter Expert (SME) for assigned process equipment throughout its lifecycle.
- Provide technical support to Manufacturing, Quality, Validation, Automation, and Engineering teams.
- Develop and maintain equipment maintenance strategies, SOPs, preventive maintenance plans, and technical documentation.
- Evaluate equipment performance trends and recommend engineering improvements to enhance reliability, maintainability, and productivity.
Equipment & Systems
Support the maintenance and reliability of equipment including, but not limited to:
- IMA internal and external vial washers, Sterilization tunnels, Vial filling and capping machines, Tray loading systems, Isolators,
- Formulation equipment, Autoclaves, Parts washers, HVAC systems,
- Secondary packaging equipment
- Laboratory equipment
- Clean utility systems supporting sterile manufacturing
Compliance & Quality
- Ensure maintenance activities are performed in accordance with GMP, EHS, Data Integrity, and site quality requirements.
- Support equipment qualification, requalification, and validation activities in partnership with the Commissioning & Qualification team.
- Lead or support change controls, deviations, investigations, CAPAs, and risk assessments related to assigned equipment.
- Maintain accurate and complete maintenance documentation within the Computerized Maintenance Management System (CMMS).
- Support internal, customer, and regulatory inspections by providing technical expertise and maintenance records.
Asset Management
- Develop and maintain equipment spare parts strategies, including critical spare identification and inventory optimization.
- Monitor equipment lifecycle performance and recommend replacement or upgrade strategies where appropriate.
- Track maintenance KPIs and drive continuous improvement initiatives to improve Overall Equipment Effectiveness (OEE).
Projects
- Lead and support capital projects involving equipment installation, upgrades, modifications, commissioning, startup, and qualification.
- Coordinate activities with equipment suppliers, contractors, and internal stakeholders to ensure successful project execution.
- Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and equipment commissioning activities.
Continuous Improvement
- Identify opportunities to improve equipment reliability, maintenance effectiveness, productivity, and operational excellence.
- Apply structured problem-solving methodologies to resolve recurring equipment issues.
- Promote a culture of safety, compliance, collaboration, and continuous improvement.
Minimum Qualifications
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering, or a related Engineering discipline.
- Minimum 7 years of maintenance engineering experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
- Demonstrated experience supporting sterile manufacturing, aseptic processing, or fill-finish operations.
- Hands-on experience maintaining vial filling, formulation, sterilization, and clean utility equipment.
- Experience supporting equipment commissioning, qualification, and validation.
- Knowledge of GMP, FDA, EMA, PIC/S, and applicable regulatory requirements.
- Experience using Computerized Maintenance Management Systems (CMMS), preferably IBM Maximo.
Preferred Qualifications
- Experience with IMA sterile processing equipment.
- Experience with TrackWise, Kneat, SAP PM, or equivalent quality and maintenance systems.
- Knowledge of Reliability Centered Maintenance (RCM), predictive maintenance, and asset lifecycle management.
- Experience leading CAPEX projects and cross-functional engineering initiatives.
- Lean Manufacturing, Six Sigma, or continuous improvement certification is an advantage.
Knowledge, Skills & Abilities
- Strong troubleshooting and analytical problem-solving skills.
- Excellent understanding of sterile manufacturing processes and GMP compliance.
- Knowledge of equipment qualification, validation, and lifecycle management.
- Strong planning, prioritization, and project coordination skills.
- Effective communication and stakeholder management abilities.
- Ability to work independently while collaborating effectively within cross-functional teams.
- Proficiency with Microsoft Office applications and engineering documentation systems.
- Ability to work safely in classified cleanroom environments while adhering to gowning and contamination control requirements.
What You'll Bring
You are a proactive engineering professional with a passion for equipment reliability and operational excellence. You thrive in a fast-paced GMP manufacturing environment, enjoy solving complex technical challenges, and are committed to delivering high-quality, compliant manufacturing operations through collaboration, innovation, and continuous improvement.
