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ELIQUENT Life Sciences · 2 hours ago

CQV Engineer

Indianapolis, IN

Part-time

Onsite

Entry, Mid Level

$80K/yr - $95K/yr

2+ years exp

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. The Validation Engineer role involves creating and maintaining validation documentation for cleanrooms and packaging equipment to ensure compliance with regulatory standards.

ConsultingMedical DeviceProfessional Services

H1B Sponsor Likely

Responsibilities

Writes procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments

Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, 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, commissioning, qualification or other technical documents, 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

Validation documentationFDA regulationsCGMP regulationsTemperature mappingP&ID interpretationSoft skills

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 basic knowledge of laboratory validation

Experience with temperature mapping

Experience with many aspects of validation

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

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.

Washington, District of Columbia, USA

501-1000 employees

https://eliquent.com

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)