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Allentown, Pennsylvania, United States
Onsite
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, 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.
Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.
Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. The Manager, Reliability Engineering (Maintenance Excellence) is responsible for leading site-wide reliability and maintenance programs to ensure safe, compliant, and efficient operation of manufacturing and packaging assets. This role drives asset lifecycle strategies, preventive and predictive maintenance programs, and continuous improvement initiatives aligned with GMP requirements and business objectives.
The position partners cross-functionally with Engineering, Operations, Quality, and Facilities to optimize equipment performance, improve overall equipment effectiveness (OEE), and ensure sustained compliance with regulatory and corporate standards. This role serves as the site owner of the Computerized Maintenance Management System (CMMS) and maintenance excellence processes, ensuring standardized, effective execution of maintenance activities by Technical Operations.
Lead, coach, and develop a high-performing reliability engineering team, fostering a culture of safety, quality, and continuous improvement.
Establish and sustain a reliability-centered maintenance (RCM) program, including preventive, predictive, and condition-based maintenance strategies.
Drive equipment reliability improvements through data analysis, root cause analysis (RCA), and implementation of effective corrective and preventive actions (CAPA).
Define and optimize preventive and predictive maintenance strategies, standards, and job plans; partner with Technical Operations to ensure effective and compliant execution of maintenance activities.
Develop, track, and analyze key performance indicators (KPIs) such as MTBF, MTTR, and schedule adherence; support Operations in improving OEE through reliability initiatives.
Ensure maintenance and reliability programs align with GMP requirements, regulatory expectations, and Thermo Fisher quality standards; partner with Quality to support compliant documentation and calibration processes.
Provide reliability engineering input into equipment design, commissioning, qualification, and lifecycle management to ensure long-term asset performance.
Lead and support continuous improvement initiatives using Lean, Six Sigma, and reliability engineering methodologies.
Develop and manage maintenance strategies related to spare parts optimization, critical spares, and vendor performance in partnership with Supply Chain and Facilities.
Support internal and external audits and inspections as a subject matter expert for maintenance and reliability systems; ensure timely and effective closure of assigned actions.
Own and govern the Operations portion of the site Computerized Maintenance Management System (CMMS), including asset hierarchy, maintenance strategies, job plans, and data integrity to enable effective preventive and predictive maintenance execution by Technical Operations.
Establish and maintain maintenance planning and scheduling standards within CMMS, ensuring clear prioritization, resource alignment, and efficient workflow execution by Technical Operations.
Applies Good Manufacturing Principles in all areas of responsibility. Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement; conducts all activities in a safe and efficient manner.
Participate in global reliability engineering initiatives and share best practices across the network, as appropriate.
Manage special projects assigned by management.
Bachelor’s degree in engineering (Mechanical, Electrical, Industrial, or related discipline) preferred.
High school diploma, or equivalent required.
Preferred Qualifications:
Six Sigma Certification or experience in Lean Manufacturing or Process Improvement Methodology
Advanced degree in Engineering or related discipline preferred.
Minimum 5 years of experience in maintenance, reliability engineering, or technical operations within pharmaceutical, biotechnology, or other regulated manufacturing environments.
Prior leadership or supervisory experience preferred.
Strong knowledge of reliability engineering principles including RCM, FMEA, and RCA.
Experience with computerized maintenance management systems (CMMS) and maintenance analytics.
Working knowledge of GMP requirements and regulatory expectations (FDA, EMA, etc.).
Familiarity with Lean Manufacturing, Six Sigma, and continuous improvement tools.
Strong analytical, organizational, and problem-solving skills.
Ability to influence without direct authority and drive change in a matrixed organization.
Demonstrated leadership capability with experience developing and leading technical teams in a regulated environment.
Strong problem-solving and analytical skills with the ability to translate data into actionable improvements.
Proven ability to work cross-functionally and influence stakeholders at multiple levels of the organization.
Strong communication skills, both written and verbal.
Ability to manage multiple priorities in a fast-paced, GMP-regulated environment.
Strong organizational, influencing, and results-oriented mindset.
Physical Requirements / Work Environment
Ability to work in a manufacturing environment, including cleanroom and warehouse areas.
Must be able to stand, walk, and perform tasks consistent with site safety requirements.
Ability to wear appropriate personal protective equipment (PPE) as required.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.