Associate Lab Support Engineer, Storage Stability [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

This is a fully- onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the U.S. 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.

The Associate Lab Support Engineer provides system analysis of new laboratory instrumentation, as well as maintenance of existing instrumentation. Assists in the validation and qualification of laboratory instrumentation. Troubleshoots and repairs existing laboratory equipment and interacts with vendors and provides repair and maintenance of analytical instrumentation. The role involves supporting laboratory personnel in meeting specific sponsor timelines regarding analytical results.

What You'll Do:
• Perform Performance Qualification (PQ) and repair on deployed instrumentation.
• Coordinate with Operations staff on deployment of instrumentation.
• Perform unit system testing to include IQ (Installation Qualification), OQ (Operation Qualification) and calibration; Perform validation testing as needed.
• Assist in developing Standard Operating Procedures and testing procedures for emerging technologies and performance qualification (PQ) regiments for existing technologies.
• Assist in the installation of new instrumentation.
• Provide basic operator training to end-users on analytical instrumentation.
• Evaluate lab support records for compliance with SOPs, review for completeness and accuracy and reports findings.

Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8 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, Abilities:
• Working knowledge and understanding of laboratory equipment and foundations of troubleshooting
• Knowledge of mass spectrometry, liquid chromatography, relational databases, and other analytical instrumentation operation
• Working knowledge with systems in use at PPD or within the CRO/Pharmaceutical industry
• Client focused approach with strong interpersonal skills
• Strong analytical and problem solving skills
• Ability to communicate effective with vendors, clients and all levels of staff
• Attention to detail and ability to multi-task
• Ability to train others
• 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 stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 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.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple 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 breakthroughs.