Maintenance Engineer I

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

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD® clinical research portfolio, our work in accelerated enrollment solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Master Job Description

1. General Job information

Business Title : Maintenance Engineer |

2. Position in the organization

Directly reports to : Manager, Maintenance/Calibrations/Facilities.

3. Purpose of the Job

The Maintenance Engineer assumes ownership for the execution and support of Maintenance and Calibration objectives. The job holder will ensure knowledge in calibration, maintenance, facilities, and utilities, delivering results on Safety, Quality, and Quantity. At Thermo Fisher we value performance, quality, innovation, and employees are encouraged to perform at their best.

4. Job and Position Context

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing Facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production. The site must align with rules and regulations of cGMP set by countries’ health and welfare ministries, internationally harmonized guidelines, regulations and with internal and external EH&S requirements and regulations.

Site activities need to be completed in an efficient and effective manner to ensure the site’s overall success.

Due to the very high value of equipment, raw materials, intermediates, and products, activities must be completed in a highly controlled fashion. Adequately planned and controlled activities, compliance to cGMP rules, and regulations and guidelines is essential for patient safety, the suitability of the clients’ products, and the license to operate for the site.

• Scientific: The job holder should have technical knowledge and expertise to field of engineering, calibration, maintenance, automation, and fit and finish.
• The job holder is responsible for carrying out maintenance and calibration activities, requiring technical knowledge and expertise as a domain expert.
• Networking: The job holder is operating in a within Thermo Fisher Scientific: Managers, Supervisors, employees of (other) departments, and as applicable with suppliers; other Thermo Fisher Scientific sites; relations within biopharmaceutical industry.
• Quality and EH&S: Responsible for acting according to EH&S, Quality, and cGMP regulations.

Job Content

Key Areas of accountability/responsibility

• The job holder’s main accountability is to ensure the ready to operate and compliant state of the installations, instruments, equipment, and facilities of the site. This includes among other calibration, preventative maintenance- and corrective maintenance schedule alignment and execution.

Main responsibilities include:

• contractor guidance and interaction,
• performing Maintenance & Calibration activities as planned and prepared by the Planner
• fixing and repairing in case of corrective maintenance and breakdowns,
• providing supporting information for quality system related actions,
• participate in the engineer on call team,

Additional responsibilities, as assigned by the manager, include:

• Automation (OT): Diagnosing automation issues, repair and maintenance (printer problems, PLC issues, patch cabinet maintenance); OT spare parts management, work with Plant Engineering for IT/OT aspects of new or modification of installations / equipment as required,
• Authority in utilities and facility including lead for HVAC stop, WFI stop, Cooling,

Project support as assigned,

• Oversight of the cleanroom state with detailed support of fit and finish activities.
• Support and understanding of preventive maintenance and calibration organization and activities when required.
• Responsible for the achievement of KPls, reporting of deviations and issues.
• Achieving assigned departmental goals in Engineering that are in line with the site and company objectives.
• Ensure that activities in the Maintenance and Calibration Department within the Thermo Fisher

Scientific Corporate guidelines, systems, and requirements, EH&S requirements, within quality and regulatory requirements (EMEA/ FDA guidelines for manufacturing).

• Responsible for continuous improvement initiatives for increased efficiency and/or costs reduction.
• Responsible for cost consciousness and cost reduction in the department.
• Authority in maintenance, calibration, utilities, facilities, automation, computerized maintenance management system.

6. Complexity of the Job

• The Biopharmaceutical industry makes use of a wide range of technologies (including cell line generation, cell culturing and purification technologies) which are characterized by strict safety and quality requirements, and pressure on timelines.
• The Maintenance Engineer is responsible for maintenance, calibration, utilities, and facilities objectives and the accountability that goes with quality in the Biopharmaceutical realm.
• The Maintenance Engineer needs to be sound in content knowledge and needs to be able to represent Thermo Fisher Scientific in a professional manner.

7. Knowledge and education level

• Higher Vocational Education, BSc or equivalent level through education, training, and experience in

Engineering or equivalent. Good command of English, both in oral and written communication

8. Required Level of Experiences

• Experience in the Biotech/ Biopharma/ cGMP environment, Engineering or Maintenance fields. Knowledge of Calibration, Facilities, Automation, or Biotechnology is beneficial. Experience with a computerized maintenance management system.

9. Competences

• Proactive approach, strong interpersonal skills, attention to detail, punctuality, dependability, and dedication to integrity in all tasks.

At Thermo Fisher Scientific, you will be part of an inclusive and collaborative environment where your contributions are valued. Our mission is to enable our customers to make the world healthier, cleaner and safer. Join us in our journey to deliver outstanding solutions and achieve remarkable outcomes!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.