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Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
The Maintenance & Reliability SME defines and implements process improvements, provides technical support to maintenance and facilities operations, and improves maintenance and asset efficiency, reduces costs, and improves product quality. This role involves collaborating with multi-functional teams, ensuring GMP standards are met, and accurately detailing our processes.
Technical Responsibilities:
Act as Maintenance & Reliability SME in all topics, projects and regulatory audit or customer audit
Develop appropriate asset management and maintenance strategy.
Setup and Lead future improvements on Maintenance & Reliability SOPs, WIs, Job Aids to ensure pioneering GMP operations
Support ongoing and future investment projects (CAPEX). Setting up and defining maintenance strategy.
Lead and implement modifications and improvements to assigned Systems to ensure maximum efficiency and uptime of equipment.
Builds and maintains partnerships PSG sites to develop and promote future maintenance strategy running several manufacturing suites in parallel.
Coordinate activities of technicians assigned to work areas to assure compliance with Company, state, and federal agency guidelines.
Define strategy with Asset Management team to ensure vital inventories of equipment and supplies are available.
Maintains planned workload work schedules and handles emergency work resulting from rendering of required Services.
Spearheads work order System within area of responsibility.
Supports Shutdown and Rolling shutdown governance and operations.
Quality:
Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management (Deviations, CAPAs, Change Control, etc.).
Actively chips in to continuous quality improvement initiatives and deviation reporting and follow-up.
Represent the department as SME for the area responsible in audits and regulatory inspections.
Safety:
Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
Actively supplies to safety initiatives and issues as well as near miss reporting and follow-up.
Values & Behaviour
Maintains dedication to Thermo Fisher Scientific values and alignment with ethics and legal compliance standards.
Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives.
Thinks and acts with a customer-centric mentality.
Is intellectually curious and accepts Practical Process Improvement (PPI).
Education
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
Master’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
Experience & Competences
Indicate the required experience for this position
Validated experience (5-7 years) in GMP maintenance engineering, within the pharmaceutical DP or DS industry.
Validated experience in maintenance management, - strategy or shutdown leadership
Strong communication
Additional Requirements
Ability to work independently and demonstrate job ownership.
Analytical and concept-based thinking and acting.
Physical ability to perform tasks that may require prolonged standing, walking, and lifting of materials and equipment.
Proficiency in working in cleanroom environments and adhering to all GMP and safety laws.
Seniority level Seniority level Not Applicable
Employment type Employment type Full-time
Job function Job function Production, Supply Chain, and Manufacturing
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Maintenance Section Manager - Implant/Metal Mechanics & Utilities Professional (Utilities focused) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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