Job Description

Reports to: General Manager, Business Segment

Direct reports: Manager Validation and plant Engineering, Manager Maintenance, Technical Project Manager, Sr. Facilities Specialist.

Purpose of the Job:

The purpose of this role is to plan, develop, and implement Facilities, Maintenance, Validation, and Engineering processes to support the commercial and manufacturing activities of Thermo Fisher in Groningen. The job holder will ensure compliance with corporate requirements and guidelines, and work towards achieving financial, business, and strategic objectives outlined in the strategic plans.

Job and Position Context:

Thermo Fisher Groningen operates as a Custom Manufacturing Organization for pharmaceutical customers, with a focus on the production of antibodies and other active pharma proteins using mammalian cell lines. The job holder will be responsible for ensuring a short but effective development process, timely transfer to Operations, and batch production under cGMP.

Thermo Fisher offers industry-standard innovative technologies, including Single Use Technologies and Single Use Bioreactors. The job holder will coordinate the transfer of 5-10 new manufacturing processes annually and acquire or develop new technologies to maintain and increase the site's success.

The Facilities, Maintenance, Validation, and Engineering activities encompass various tasks, from planning facilities, equipment expansion, and refurbishment to life cycle management, ongoing improvements, and compliance with cGMP and EH&S regulations. The diverse customer base and associated products require a wide range of activities.

The job holder must ensure compliance with cGMP regulations set by health and welfare ministries and internationally harmonized guidelines. They must also consider internal and external EH&S requirements and regulations.

Efficiency, effectiveness, and control are crucial in driving the department's success. Given the high value of equipment and materials, mistakes can be costly. Compliance with cGMP rules, regulations, and guidelines is important for patient safety, product suitability, and maintaining the site's license to operate.

Scientific responsibilities include ensuring the manufacturing environment meets quality and quantity standards. The job holder must ensure personnel availability, equipment condition, and accurate execution of manufacturing processes. Significant technical knowledge and expertise in Pharmaceutical and/or Biotech Facilities, Maintenance, Validation, and Engineering are required.

Responsibilities involve leading several sub-departments and demonstrating excellent leadership and mentorship skills to achieve departmental results.

Networking responsibilities involve collaborating with internal customers, such as the Site Leadership Team, managers, supervisors, and employees of various departments, as well as external partners, such as clients, suppliers, authorities, and other Thermo Fisher sites. Establishing relationships within the biopharmaceutical industry is also important.

Quality and EH&S responsibilities involve acting following EH&S, Quality, and cGMP regulations. The job holder must ensure activities are performed under safe conditions, guarantee the health of engineers and technicians, and prevent negative environmental impacts.

Job Content Key Areas of Accountability/Responsibility:

• Lead the Facilities, Maintenance, Engineering department, setting targets and standards, defining priorities, and measuring output and results.

• Develop and implement the yearly Facilities, Maintenance, Engineering plan aligned with business needs and strategy, including strategic goals, cost budgeting, and investment management.

• Supervise Key Operating Parameters, EH&S systems, and policies for the whole site.

• Stay updated on technological, logistic, legal, and regulatory developments and assess their applicability and consequences for Thermo Fisher Groningen.

• Drive continuous improvement in costs and results within the department.

• Build and maintain a safe and balanced working environment, ensuring compliance with EH&S and operational requirements.

• Apply HR policy in line with Thermo Fisher Corporate and guidelines, including implementing HR structures and systems.

• Manage and mentor department managers to meet current and future workforce requirements and maintain cGMP compliance.

Authorities:

• Deputize for other Site Leadership Team members in Groningen.

Complexity of the Job:

The Biopharmaceutical industry applies a wide range of technologies, and the Facilities, Maintenance, Engineering Sr. Manager is responsible for their proper execution. There must be alignment between the Maintenance, Validation, Engineering, and Facilities departments. Safety, quality, and timeline pressures are inherent in all processes.

The job holder will frequently get along with customers, including high-level executives, during site visits. Content knowledge and professional representation of Thermo Fisher are important.

Efficient and effective implementation of Facilities, Maintenance, Validation, and Engineering services is essential for the site's success. Mistakes can be costly due to the high value of raw materials, intermediates, and products.

In urgent situations requiring immediate response, the Facilities, Maintenance, Engineering Sr. Manager may need to make decisions without consulting the General Manager.

Knowledge and Educational Level:

• Master's degree in Engineering or equivalent in Engineering, Chemistry, Biology, Biochemistry, or Bioprocess Technology.

• Knowledge and experience in facilities for manufacturing biologics.

• Knowledge and experience in Validation, Maintenance, and Engineering.

Required Level of Experience:

• Proven experience in a senior managerial role.

• Expertise in Facilities, Maintenance, Validation, and/or Engineering in a Biotech/Biopharma/cGMP environment.

Competencies:

• Planning and organization skills.

• Leadership and mentorship skills.

• Proficient in English.

• Interpersonal skills.

• Presentation skills.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.