Maintenance & Reliability SME

Thermo Fisher Scientific; Lengnau BE; Vor Ort; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific is seeking a Maintenance & Reliability SME in Lengnau BE, Switzerland. This role focuses on defining and implementing maintenance solutions, ensuring GMP compliance, and leading teams in driving asset efficiency. Ideal candidates should have extensive experience in pharmaceutical maintenance engineering and hold relevant degrees. Apply to be part of an innovative organization dedicated to improving product quality and performance.

Qualifikationen

• 5-7 years' validated experience in GMP maintenance engineering within the pharmaceutical industry.
• Experience in maintenance management and strategy.
• Ability to work independently and demonstrate job ownership.
• Proficiency in working in cleanroom environments and adhering to all GMP and safety laws.

Aufgaben

• Defines and implements process improvements.
• Provides technical support to maintenance and facilities operations.
• Improves maintenance and asset efficiency.
• Reduces costs and improves product quality.
• Collaborates with multi-functional teams to ensure GMP standards are met.

Kenntnisse

GMP maintenance engineering

Maintenance management

Shutdown leadership

Strong communication

Ausbildung

Bachelor’s degree in Mechanical Engineering

Master’s degree in Mechanical Engineering

Jobbeschreibung

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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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