ELIQUENT Life Sciences · 2 months ago
Validation Engineer
US
Full-time, Part-time
Hybrid
Mid Level
$95K/yr - $95K/yrELIQUENT Life Sciences is a leading global consulting firm providing solutions to life science companies. They are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to ensure successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries.
ConsultingMedical DeviceProfessional Services
Responsibilities
Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of Facilities and Utilities (air handling units, HVAC)
Coordinate and oversee the installation, testing, and validation of equipment and systems
Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP)
Conduct environmental monitoring performance qualification
Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments
Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports
Identify and resolve deviations and non-conformities, ensuring timely corrective actions
Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met
Provide technical guidance and mentorship to junior team members
Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities
Stay current with industry trends, technological advancements, and regulatory changes
Qualification
Required
BS in Engineering, Science or equivalent technical degree
Experience with EMPQ and temperature mapping
Solid understanding of GMP regulations and industry standards
Excellent communication and interpersonal skills
Ability to work independently and collaboratively in a dynamic team environment
Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand
Strong analytical and problem-solving skills with attention to detail
Understand and translate requestor's strategies into plans, and be able to drive the project to completion
Benefits
Health, dental, vision, and life insurance
401(k) plan with employer match
Generous paid time off policy
Additional perks
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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