Metrologist - Storage Stability

RXinsider LTD.; Town of Middleton (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific in Middleton, WI is seeking a Laboratory Instrumentation Technician to maintain active instrumentation and support GMP laboratory activities. This onsite role covers IQ/OQ/PQ, installation oversight, and vendor documentation review.

Applicants should have a high school diploma or equivalent, plus relevant qualifications and at least four years of related experience. Occasional travel not mentioned.

Qualifications

• Knowledge of FDA and GXP regulations and requirements.
• Experience with laboratory instrumentation and equipment.
• Familiarity with CRO/pharma lab systems.
• Strong troubleshooting and problem-solving abilities.
• Client-focused with strong interpersonal skills.
• Effective communication with vendors, clients and staff.
• Able to work in a collaborative team environment.

Responsibilities

• Perform routine and remedial maintenance on active instrumentation and equipment.
• Perform calibrations/qualifications (IQ/OQ/PQ) on equipment.
• Provide installation oversight of new laboratory instruments and equipment.
• Review vendor documentation related to PM, calibration/qualification and repairs.
• Assist and prepare SOPs for operation, maintenance and calibration of lab equipment.
• Address audits (internal or external) on laboratory instruments and equipment.
• Evaluate lab support records for SOP compliance and accuracy.

Skills

FDA and GXP regulations

Laboratory instrumentation knowledge

Vendor & client communication

Troubleshooting

Interpersonal skills

Team collaboration

Education

High/Secondary diploma or equivalent

Technical certificate (optional)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

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.