Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
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, such as protecting the environment, ensuring our food is safe, and finding cures for cancer.
DESCRIPTION:
Senior Engineer - Utilities
The incumbent will provide direction and supervision to support utilities system maintenance and operation in compliance with cGMP, EHS, Data Integrity, and regulatory requirements for the Sterile manufacturing site
Responsibilities
- Responsible for the operation and maintenance of utilities and facilities systems, but not limited to WFI, RO, HVAC, chiller, boiler, air compressor, and nitrogen systems
- Work closely with the validation team to complete the qualification and re-qualification of the facilities and utilities systems
- Draft and prepare maintenance and operation SOP and PM plan for facilities and utilities systems
- Responsible for utilities and facilities systems-related changes and deviation management
- Cooperate with the internal and external audit team
- Responsible for utilities and facilities system-related small CAPEX project execution in the future
- Responsible for the utilities and facilities shutdown plan and execution
- Review as-built drawings and engineering technical data, and performance data for the facilities and utilities system
- Support a third-party vendor who is contracted to perform routine inspection, preventive maintenance, corrective maintenance, and any other maintenance-related activity
- Support the maintenance KPI based on the site engineering and quality requirements for utilities and facilities
- Complete all routine maintenance works as scheduled and in compliance with Engineering standards and safety procedures
- All GMP documentation related to maintenance activities is completed accurately and processed to full completion in compliance with data integrity requirements
- Ensure compliance with cGMP, regulatory requirements, and the company Quality Management System (QMS) for all utilities and facilities activities
- Participate in deviation investigation, root cause analysis, and implementation of effective CAPA for utilities and facilities systems
- Support risk assessments (e.g., FMEA) related to facilities and utilities to ensure product quality and patient safety
- Ensure all documentation (SOPs, logbooks, reports) aligns with data integrity principles (ALCOA+) and quality standards
- Support change control processes by assessing the quality and regulatory impact of proposed changes
- Collaborate with Quality Assurance (QA) to ensure readiness for audits and inspections
- Monitor and trend utilities performance data to identify quality risks and drive continuous improvement
- Ensure vendors and contractors comply with site quality requirements and GMP standards
- Participate in periodic quality review meetings and contribute to continuous improvement initiatives
- Carry out any other duties and responsibilities as assigned by the line manager, including but not limited to the above
Minimum Requirements/Qualifications
Education:
- University degree in engineering
Experience:
- 6 to 8 years of proven experience in maintenance of utilities and facilities systems, and related validation/GMP issues
- Has working experience in using the Building Management System and the Environmental Monitoring System
- Understanding of electrical standards, local requirements, and general electrical safety best practices
- SAP/CMMS experience is an advantage
Competencies:
- Able to work in a fast-paced and regulated environment
- Able to plan, schedule, organize, prioritize, and coordinate project activity
- Strong understanding of facilities systems related validation / GMP requirements
- Strong troubleshooting skills and a good knowledge of different RCA tools
- Able to work independently and perform machine maintenance work
