Senior Metrologist - Chromatography

Thermo Fisher Scientific • Middleton, WI

4d

About The Position

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. Discover Impactful Work: 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. A day in the Life: 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 solve 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.

Requirements

• 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.
• Understanding of FDA and GXP regulations and requirements
• Working knowledge and understanding of laboratory instrumentation and equipment
• Working knowledge with systems in use at PPD or within the CRO/Pharmaceutical industry
• Ability to train others
• Client focused approach with strong interpersonal skills
• Analytical and critical thinking skills
• Troubleshooting abilities
• Ability to communicate effectively with vendors, clients and all levels of staff
• Ability to work in a collaborative team environment

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 solve 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level