2+ years of hands-on experience in a GMP-regulated environment, particularly in commissioning, qualification, or validation activities.
Understanding of IQ, OQ, and PQ processes and their importance in qualification documentation.
Ability to interpret technical drawings, especially P&IDs.
Strong technical writing skills for regulatory documentation.
Familiarity with cGMP regulations under 21 CFR Parts 210 and 211, and good documentation practices.
Degree in engineering, microbiology, or life sciences preferred; equivalent experience considered.
Detail-oriented and methodical, with a focus on maintaining accurate documentation.
Responsibilities
Author and execute commissioning and qualification protocols for utilities, equipment, and facilities.
Perform field verification and walkdowns against P&IDs, logging discrepancies for resolution.
Execute qualification sampling programs and maintain accurate records, including sample logs and chain of custody.
Write deviation and summary reports, supporting investigations as needed.
Assist in risk assessments and FMEAs, and develop corresponding sampling plans.
Support change control processes and help finalize qualification packages.
Collaborate with client engineering and quality teams on-site, representing the company professionally.
Benefits
Comprehensive medical coverage, including dental and vision options.
Life and disability insurance.
401(k) plan with company match.
Paid vacation and holidays.
Full Job Description
Job Description
This is a hands-on commissioning, qualification and validation role with high growth potential. You will work alongside our CQV Lead on facility, utility and equipment qualification programs for pharmaceutical and biotechnology clients - writing and executing protocols, working in the field, and building toward owning systems independently.
We are looking for someone with real GMP experience who wants to move further into validation than their current role allows.
Author and execute commissioning and qualification protocols - IQ, OQ and PQ - for utilities, equipment and facilities.
Perform field verification and walkdowns against P&IDs, and log discrepancies for resolution.
Execute qualification sampling programs and maintain complete, accurate records - sample logs, chain of custody and executed protocols.
Write deviation reports and summary reports, and support investigations.
Support risk assessments and FMEAs, and the sampling plans that follow from them.
Support change control, and help close out qualification packages.
Work with client engineering and quality teams on site, representing Eurofins professionally.
As you grow: take ownership of systems end to end, mentor newer engineers, and lead your own qualification workstreams.
Qualifications
Must haves:
Two or more years of hands-on experience in a GMP-regulated environment, with direct involvement in commissioning, qualification or validation activity. We will consider strong candidates from adjacent roles - QC or laboratory analysts who have executed equipment qualifications, calibration and metrology technicians, manufacturing or maintenance engineers from a pharmaceutical site.
A working understanding of IQ, OQ and PQ, and of why qualification documentation matters.
Ability to read and work from technical drawings, particularly P&IDs.
Clear technical writing. Much of this role is producing documents that a regulator may read.
Familiarity with cGMP under 21 CFR Parts 210 and 211, and with good documentation practice.
Degree in engineering, microbiology or a life science is preferred. Equivalent hands-on experience will be considered in its place.
Careful, accurate and methodical. Comfortable being held to a document trail.
Valid driver's licence. Able to work on active construction and manufacturing sites, including gowned work and occasional extended hours during qualification campaigns.
None of the following are expected on day one. Each is something we will teach, and each is a reason to put your application forward.
Utilities experience - water for injection, purified water, clean steam, compressed air, nitrogen, oxygen.
Environmental monitoring, aseptic operations, or cleanroom experience.
MODA, LIMS or other electronic data systems, and computer system validation under GAMP 5.
Risk assessment methodology under ICH Q9, or FMEA facilitation.
EU GMP Annex 1, ISO 14644, or USP compendial testing requirements.
Electronic validation platforms such as Kneat.
Additional Information
Positions are full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to Edison, NJ are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
About Eurofins Lancaster Laboratories
Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
