Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Purpose of the job

·         Ensure that all mission critical process equipment/systems remain continuously ready for safe, effective, efficient, and compliant operations

·         Establish and streamline activities around equipment and/or facility specification, design, start-up, and commissioning & qualification

Job and Position context

As part of the team at Thermo Fisher Scientific, we're doing important work. Surrounded by collaborative colleagues, we offer you the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. 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.

Scientific:

• Technical Leader with respective “Mission Critical” equipment/system/facility area
• Drive equipment capabilities and capacity to realize the site’s growth trajectory
• Build business cases for new capital projects utilizing payback modeling
• Drive of Lean Manufacturing principles
• Scope development projects and basis of design
• System and field device troubleshooting and testing
• Establish and operate against an equipment/facility roadmap
• Establish & maintain the equipment compliance posture (Safety, Health, cGMP, BioSafety, Waste), predominantly focused around automated systems
• Work with the Process Engineering department to support the facility fit analysis of new production processes
• Conduct all activities in accordance with cGMP and EH&S

Organization:

• Ensure all equipment systems remain continuously ready for safe, effective, efficient, and compliant operations
• Behave as a Change Agent to drive innovation and operational effectiveness
• Engage with functional department leaders to establish an understanding of the needs/requirements of the department from an equipment capability and capacity perspective
• Contribute to equipment and space roadmap to support the site master plan

Networking: The job holder is operating in a wide network within and outside Thermo Fisher Scientific:

Internal:

• Manufacturing Science & Technology transfer representatives
• Quality representatives
• Manufacturing representatives
• Facilities & Maintenance representatives

External:

• Vendors (retrieving information with regard to use and delivery times of items are not stocked or regularly ordered by Patheon)

Quality and EH&S: Responsible for acting according to EH&S, Quality and cGMP regulations. Activities have to be performed under safe conditions.

Job Content Key Areas of accountability/ responsibility

• Technical expertise in one or more of the following “Mission Critical” Equipment/System areas:

• Upstream Processing (USP)
• Downstream Processing (DSP)
• Laboratory & Analytical Instruments (LAI)
• Medias, Buffers & Support (MBS)
• Architectural, Facilities & Warehouse (AFW)
• Plant & Clean Utilities (PCU)

• Equipment and Systems Roadmap

• Responsible for performing department activities, with responsibility for results on Safety, Quality, and Quantity:

• Responsible for achieving targets and standards in the department;
• Responsible for achieving priorities in the planning of actions and resources;
• Responsible for achieving assigned and/or agreed departmental goals;
• Measure the output and report results, deviations and issues.

• Validation Master Plan and assigned site validation activities for Thermo Fisher Scientific Groningen in line with business needs and strategy:

• Achieving (some of the) strategic goals set for the department, which are in line with the corporate goals;
• Achieving the yearly plans of the department;
• Responsible for cost reduction in fixed costs within the department;
• Responsible for cost consciousness in variable cost within the department;
• Responsible for monitoring of the Key Operating Parameters of the department.

• Monitor external technological, legal and regulatory developments in the area of Engineering and assess their applicability to and consequences for Thermo Fisher Scientific Groningen Site;
• Responsible for continuous improvement in costs and results within Engineering activities;
• Responsible for EH&S in Engineering activities:

• Responsible for creating and maintaining a safe and healthy working environment;
• Ensure that activities at Thermo Fisher Scientific Groningen are within the EH&S requirements;
• Ensure that activities in the department are within regulatory requirements (EMEA/ FDA guidelines for manufacturing);
• Foster the awareness for EH&S and Quality within Thermo Fisher Scientific Groningen.

• Act according Thermo Fisher Scientific Corporate and Thermo Fisher Scientific guidelines, systems, and requirements;
• Responsible for managing and coaching contractors:

Manage contractors that meets current and future requirements in terms of quality and quantity in order to establish and maintain cGMP compliance.