Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Purpose

When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

 

The Manager, Maintenance and Utilities is responsible for ensuring the efficient and compliant operation of all mechanical systems and non-electrical energy systems, such as boilers and clean steam, within the Lengnau facility. This role is critical to maintaining the high-tech, fully automated stainless steel GMP manufacturing facility dedicated to large-scale monoclonal antibody (MAB) production for human use. Within the responsibility of this role is also the day-to-day operations 24/7 of the GMP and Non-GMP Utility systems.

Position Responsibilities & Accountabilities

Manage Daily Operations: Be responsible for the day-to-day activities of the Maintenance and Utilities Team, ensuring smooth and efficient operations.Team Leadership and Management: Lead, mentor, and develop the maintenance team to foster a high-performance culture. Provide clear direction, set performance expectations, and conduct regular performance evaluations. Foster a collaborative and inclusive work environment that encourages team members to share ideas and contribute to continuous improvement initiatives. Ensure the team is adequately trained and equipped to perform their duties safely and effectively.Assign tasks, inspect work, review documentation, and develop training programs.Regulatory Compliance & Statutory Inspections: Ensure all mechanical systems and non-electrical energy systems follow relevant health, safety, and environmental regulations, including GMP standards for the manufacturing of monoclonal antibodies (MABs) for human use. Be responsible for statutory inspections across all production areas, including cleanrooms and energy plants. Collaborate closely with quality assurance and legal teams to meet compliance standards and prepare for audits by regulatory bodies such as the FDA, EMA, and Swissmedic.CMMS Management: Use the site’s implemented Computerized Maintenance Management System (CMMS), One Maximo, to supervise and manage maintenance activities, ensuring transparency and efficiency. Be responsible for the scheduling and execution of maintenance tasks to ensure optimal equipment reliability and minimal downtime.Planned Preventative & Predictive Maintenance: Develop and implement a Planned Preventative Maintenance (PPM) program tailored to the high-tech, fully automated stainless steel GMP manufacturing facility. Use predictive maintenance technologies to supervise equipment conditions, ensuring the reliability of critical systems such as boilers and clean steam generators.Mechanical Systems and Non-Electrical Energy Infrastructure: Lead the maintenance of all mechanical systems, including large-scale stainless-steel reactors (12K L), boilers, and clean steam systems. Ensure the mechanical systems and non-electrical energy systems are maintained to support uninterrupted GMP manufacturing operations.Perform Additional Duties: Carry out additional responsibilities as assigned to support the overall success of the facility.

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 contributes to continuous quality improvement initiatives and deviation reporting and follow-up.Represent the department as SME for the responsible area in audits and regulatory inspections.

EHSS

Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.

Values & Behaviour

Maintains commitment to Thermo Fisher Scientific values and alignment to ethics and legal compliance standards.Takes personal accountability for their presence, performance, and productivity for the achievements of defined objectives.Thinks and acts with a customer-centric attitude.Is intellectually curious and embraces Practical Process Improvement (PPI).

Position Qualifications

Education

Bachelor’s degree in Engineering, Mechanical Engineering, Process Engineering, or a related field (or equivalent experience).

Experience & Competences

Minimum of 7-10 years of experience in maintenance management, preferably in a high-tech, automated GMP manufacturing facility.Demonstrated experience in managing mechanical systems and non-electrical energy systems, such as boilers and clean steam.Proven track record of leading and developing high-performance maintenance teams.In-depth knowledge of GMP standards in manufacturing settings, particularly for human-use MAB production is an advantage.Strong understanding of GMP standards and maintenance requirements (NIST/USP/ISO).Experience managing cross-disciplinary teams and maintaining complex, highly regulated environments.Strong understanding of relevant regulatory frameworks (e.g., GMP, health and safety, environmental standards).Proven experience in using CMMS, particularly One Maximo, to manage maintenance operations across large, diverse facilities.

Additional Requirements

Experience in managing maintenance and mechanical systems in a high-tech, automated manufacturing facility.Lead with an open attitude passionate about efficient problem solving.Strong project management skills and the ability to lead multiple concurrent projects.Excellent communication and interpersonal skills, with the ability to collaborate effectively with multi-functional teams.Participation in quality improvement initiatives and deviation reporting.Analytical and concept-based thinking and acting.Six-sigma, process improvement or related experiences are and advantage