Metrologist - Storage Stability

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description This is a fully onsite role based at our GMP Laboratory 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. As a Metrologist, your role will be to lead the maintenance, calibration, and optimization of advanced laboratory instruments, ensure their precise functioning, troubleshoot complex technical issues, and enhance the overall efficiency and reliability of lab operations. What You’ll Do: • Perform routine and remedial maintenance on active instrumentation and equipment. • Perform Calibrations/Qualifications on active instrumentation and equipment to include IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification). • Provide installation oversight of new laboratory instrumentation and equipment. • Review vendor documentation relating to pm, calibration/qualification and repairs. • Assist and prepare SOPs pertaining to operation, maintenance and calibration of laboratory instrumentation and equipment. • Address audits (internal or external client) on laboratory instruments and equipment. • Evaluate lab support records for compliance with SOPs, review for completeness and accuracy and reports findings. Education and Experience: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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 GXP regulations and requirements • Knowledge and understanding of laboratory instrumentation and equipment • Working knowledge with systems in use at PPD or 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 collaborative team environment Working Conditions and Environment: • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. • Occasional drives to site locations, occasional domestic travel. • Exposure to biological fluids with potential exposure to infectious organisms. • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions. Physical Requirements: • Frequently stands, twists waists, squats, and bends neck for 4--6 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. • Frequent mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • Moderate lifting (or otherwise movement, carrying, setting, and placement)of 15-30 lbs. with a maximum lift of 35 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • May interact with others, relating and gathering sensitive information. Interaction includes diverse groups. • Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthrough.