Sr. Metrologist - GMP Lab

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Working at heights

Job Description

This is a fully onsite role based at our GMP Lab in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  

Must be legally authorized to work in the United States without sponsorship. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

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 - enabling 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations

Summary:

Provides maintenance on various laboratory instrumentation and equipment. Maintenance includes installation, routine and remedial maintenance, calibration and/or qualification, and at times troubleshoots. Work is performed independently and documented in accordance with standard operating procedures and established maintenance schedules to meet regulatory requirements. Works with lab staff and schedules maintenance and trains others on equipment as needed. Trains, mentors, and provides oversight to junior level staff responsible for the same tasks.

Responsibilities:

• Performs scheduled maintenance on active instrumentation and equipment.

• Performs scheduled calibrations/qualifications on active instrumentation and equipment to include IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).

• Independently writes and reviews qualification documentation. Performs remedial maintenance on active instrumentation and equipment and problem solves issues.

• Oversees and manages installation of new laboratory instrumentation and equipment.

• Trains end users on existing instrumentation and equipment as required.

• Prepares SOPs pertaining to operation, maintenance and calibration of laboratory instrumentation and equipment.

• Addresses audits on laboratory instruments and equipment. • Evaluates lab support records for compliance with SOPs, reviews for completeness and accuracy and reports findings.

Education and Experience:

• Bachelor's degree in engineering or science field or equivalent and relevant formal academic / vocational qualification.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Understanding of FDA and GMP regulations and requirements

• Knowledge and understanding of laboratory instrumentation and equipment

• Working knowledge with systems within the CRO/Pharmaceutical industry

• Troubleshooting, analytical and problem-solving skills

• Client focused approach with strong interpersonal skills

• Ability to communicate effectively with vendors, clients and all levels of staff

• Ability to work in a