ELIQUENT Life Sciences · 20 hours ago
Validation Engineer
New Albany, OH, US
Full-time
Onsite
Entry, Mid Level
$80K/yr - $90K/yr
2+ years expELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. They are seeking an experienced Validation Engineer to join their Columbus team, responsible for ensuring compliance of validation documentation with regulatory expectations and corporate policies.
ConsultingMedical DeviceProfessional Services
Responsibilities
Writes procedures, protocols, reports, etc. to support the Maintenance, Engineering, Validation, Quality, and Regulatory departments
Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, facilities, utilities, systems, and equipment qualification/requalification
Writes and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation test plans, engineering design reviews, user requirement specifications (URS), functional requirement specifications(FRS), detailed design specifications, factory acceptance test documents (FAT), and/or commissioning test procedures
Performs on site or support work for a client under supervision, including but not limited to:
Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature-controlled chambers, warehouses, and sterilization processes
Equipment Qualification test execution
Investigations and deviations
Risk analysis, and/or
Data integrity assessments and review of client data
Executes protocols and helps resolve deviations/discrepancies, analyze study data and write summary reports, under supervision of senior consultants
Qualification
Required
Bachelors Degree in engineering, science, or similar field or equivalent experience
2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
Experience in executing protocols including systems such as process validation, utilities, manufacturing equipment and laboratory validation
Experience with temperature mapping
Working knowledge of FDA and cGMP regulations and documentation practice
Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
Benefits
Competitive Compensation
Health, dental, vision, and life insurance
A 401(k) plan with employer match
A generous paid time off policy
Additional perks
Opportunities for professional growth and advancement within a supportive and innovative environment.
Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Company
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
501-1000 employees
H1B Sponsorship
ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)
Funding
Current Stage
Late StageLeadership Team
Stephen Purtell
Chief Financial Officer
Rob Wojciechowski
Chief Operating Officer
Recent News
2025-05-08
globallegalchronicle.com
2025-04-07
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