Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

As a Senior Metrologist you will provide 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 stablished maintenance schedules to meet regulatory requirements. You will work collaboratively with lab staff and schedule maintenance and train others on equipment as needed.

What You'll Do:
• Perform scheduled maintenance on active instrumentation and equipment. Perform scheduled calibrations/qualifications on active instrumentation and equipment to include IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).
• Independently write and review qualification documentation. Perform remedial maintenance on active instrumentation and equipment and problem solves issues.
• Oversee and manage installation of new laboratory instrumentation and equipment.
• Train end users on existing instrumentation and equipment as required.
• Prepare SOPs pertaining to operation, maintenance and calibration of laboratory instrumentation and equipment.
• Address audits on laboratory instruments and equipment.
• Evaluate lab support records for compliance with SOPs, review for completeness and accuracy and report findings.

Education & Experience 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.

Knowledge, Skills, Abilities:
• 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
• Trouble shooting abilities
• Ability to communicate effectively with vendors, clients and all levels of staff
• Ability to work in a collaborative team environment

Working Conditions/Environment and Physical Requirements:
• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office and laboratory 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.
• Long, varied hours required occasionally.
• Ability to work in an upright and /or stationary position 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 to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, luggage and laptop computer with a maximum lift of 75 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.