Assoc Metrologist (Clinical Lab Instrumentation Associate II)

Thermo Fisher Scientific•Middleton, WI

12d•Onsite

About The Position

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. Discover Impactful Work: Provides maintenance on various laboratory instrumentation and equipment under direction from senior staff. Installs, calibrates, and qualifies routine and remedial maintenance. Performs and documents work 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. A day in the Life: Performs scheduled routine 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). Performs remedial maintenance on active instrumentation and equipment. Provides installation oversight of new laboratory instrumentation and equipment. Follows vendor documentation relating to PM, calibration/qualification and repairs. Addresses audits (internal or external client) on laboratory instruments and equipment. Evaluates lab support records for compliance with SOPs, reviews for completeness and accuracy and reports findings.

Requirements

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 2 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
Basic 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
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

Provides maintenance on various laboratory instrumentation and equipment under direction from senior staff.
Installs, calibrates, and qualifies routine and remedial maintenance.
Performs and documents work 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.
Performs scheduled routine 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).
Performs remedial maintenance on active instrumentation and equipment.
Provides installation oversight of new laboratory instrumentation and equipment.
Follows vendor documentation relating to PM, calibration/qualification and repairs.
Addresses audits (internal or external client) on laboratory instruments and equipment.
Evaluates lab support records for compliance with SOPs, reviews for completeness and accuracy and reports findings.