CQV Engineer || and GCEAD and|| Onsite Greater Indianapolis Area, Indiana

Indianapolis, IN, US • Posted 1 day ago • Updated 1 day ago

Contract Independent

Contract W2

Travel Required

On-site

Depends on Experience

Fitment

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Job Details

Skills

GMP
OQ
IQ
Manufacturing
Regulatory Compliance
Pharmaceutics
CQV

Summary

Role - CQV Engineer

Location - Onsite Greater Indianapolis Area, Indiana(LP2 facility)

Duration - 12‑Month Contract

Visa – and GCEAD and

We are supporting a major pharmaceutical site expansion and are looking for an experienced CQV Engineer to join an onsite team in greater Indianapolis, Indiana. This is a long‑term contract opportunity with hands‑on execution responsibilities in a GMP manufacturing environment.

Key Responsibilities

Execute Commissioning, Qualification, and Validation (CQV) activities onsite
Perform IQ/OQ execution for cGMP equipment and systems
Author, route, execute, and approve validation documentation using KNEAT
Conduct equipment and system testing; document results electronically in real time
Generate test scripts, acceptance criteria, and traceability deliverables
Manage deviation documentation and resolution within digital workflows

Maintain inspection‑ready validation packages in compliance with GMP standards

Required Experience

Hands‑on CQV execution experience in GMP manufacturing environments
Strong working knowledge of KNEAT digital validation platform
Experience executing IQ/OQ (PQ exposure a plus)
Ability to support documentation‑heavy validation projects

Preferred (Nice to Have)

Site expansion, greenfield, or brownfield project experience
FAT/SAT coordination and startup validation exposure

Background in pharmaceutical, biotech, or CDMO manufacturing environments

Additional Details

Location: Onsite -Greater Indianapolis Area, Indiana (LP2 facility)
Start Date: TBD

Mohit Joshi | Kappium LLC
Sr. Technical Recruiter
Email:

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91173029
Position Id: 8927184
Posted 1 day ago

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