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, like protecting the environment, making sure our food is safe or helping find cures for cancer

Location/Division Specific Information

This position supports the Quality Control Laboratory and Support teams for our Biologics Division in St. Louis, MO.

Discover Impactful Work:

The Scientist II (QC Equipment Coordinator) position will serve as a liaison between the QC Group, TFS Engineering group, clients, and vendors. He/She/ will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to QC Equipment commissioning, maintenance and decommissioning activities, scheduling, and planning. This individual will be assigned and manage ongoing equipment projects for the Quality Control functional teams. This role does support QC laboratory equipment; however, it is not a role that performs product, stability, or raw material testing.

A day in the Life:

• Manage service and maintenance of all QC-owned equipment.
• Schedule all service for equipment, coordinating with vendor, service provider of TFS metrology group, including but not limited to PM scheduling, calibration.
• Asset management-commissioning of new QC equipment, removal and/or disposal of all QC-owned equipment that needs decommissioned.
• Follow up with QC management, TFS metrology, vendor, or service provider to ensure all work has been performed.
• Field repair calls, coordinate repair needs, maintenance, or other services which also includes processing routine quotes into the site’s purchasing system (Ariba), and negotiate payment for all service performed.
• Prepare and maintain service records for QC equipment.
• Collect QC equipment on a regular basis that needs to be calibrated or serviced either internally or externally by a vendor. Prepare and schedule equipment related shipments as needed for external services.
• Return ‘Completed’ equipment back to the QC laboratories as their services/repairs are made.
• Manage QC equipment commissioning program as assigned - Including tracking of timelines, scheduling interdepartmental (Validation group, Metrology, Engineering, ect.) meetings, providing update reports to QCEC management, and clearly communicating timeline risks and challenges.
• Coordinates with QC management on the evaluation of changes int eh validated/equipment laboratory equipment, selection, or evaluation of new equipment, and approving new or modified calibration/PM criteria that impact the safety, identity, strength, or quality of the product.
• Reviews the calibration/Verification or PM data to ensure that the equipment is calibrated according to predetermined schedules and procedures.
• Independently writes SOP's Change controls, project plans, equipment calibration/PM procedures.
• Processes records related to equipment in the site's QMS System: 1 Trackwise.
• Serve as liaison for external vendors who travel to the facility for repairs, maintenance, or other services.
• Process SAP related paperwork to either enter, update, or complete tasks/work orders in the site’s SAP system.
• Author or revise documents related to equipment or QC equipment processes, as assigned.
• Monitor and maintain the QC Equipment PM/CAL due list. Build spreadsheets and other tools to track assets and schedule equipment PMs accurately and efficiently.
• Maintain compliance in assigned work and follow all safety procedures, including the use of Person Protective Equipment and documentation of all activities to meet cGMP/cGDP requirements.
• Serves as a subject matter expert during regulatory and/or vendor audits, through understanding of EU and US regulatory requirements for laboratory equipment.
• Assure all laboratory equipment procedures are aligned with the current compendia (such as USP/NF, EP, or other regulatory reference) requirements.
• Other duties within the quality department as required.

Keys to Success:

• Education
• High School Diploma required.
• Associate or bachelor’s degree in a Science or Engineering related field (Biology, Biochemistry, or Chemistry)preferred. Other degree majors may be considered but not required.
• Experience
• 3-5 years related experience working in a GMP regulated industry - pharmaceutical or biopharmaceutical industries are preferred.
• Basic knowledge of scientific principles for a wide range of analytical techniques strongly preferred.
• Routine use of MS Excel, MS PowerPoint, MS Word and Visio is important.
• 1-2 years’ experience with quality management systems, trackwise preferred - processing Change Controls, Deviations, and/or CAPA's related to quality control are preferred.
• At leat 1 year experience with company ordering systems for purchase requisitions/purchase order processing are preferred.

Knowledge, Skills, Abilities

• Routine use of Microsoft Office applications is essential to this role.
• Strong written and oral communication skills.
• Highly organized with attention to detail.
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables), project management skills.
• Strong organizational skill in monitoring QC equipment activities in progress.
• Excellent communication skills - Coordinate and communicate with QC management, Metrology, Contractor, service provider for QC equipment related needs and issues.
• Working knowledge of cGMPs and quality Control regulatory requirements.
• General knowledge of simple to moderately complex instrumentation and laboratory techniques is a plus. This can either be through previous employment or in an academic setting.
• Ability to thrive in a fast paced, high demand environment.
• Strong and thorough documentation practices.
• Strong organizational skills in monitoring QC equipment activities in progress.

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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.