Validation Engineer (6-Month Backfill Contract) – 100% Onsite
Location:
Onsite (no hybrid/remote option)
Duration:
6-Month Contract
Experience Required:
Minimum 5 years
Start:
ASAP
About the Role
We are seeking an experienced
Validation Engineer
to support a 6-month backfill within a highly regulated pharmaceutical/medical device/diagnostics environment.
This role requires full onsite presence and hands-on execution of validation activities across facilities, utilities, equipment, processes and automation systems.
Key Responsibilities
Lead, coordinate, and actively participate in the
validation of equipment, facilities, utilities, processes, and software
in accordance with company policies and global regulatory standards (FDA, EU cGMP, GAMP).
Perform
risk-based qualification
activities, including Equipment Risk Assessments and development of Critical Elements Test Plans.
Execute
Commissioning & Qualification
tasks, including
IQ, OQ, and PQ
for facilities, utilities and equipment.
Support and execute
PPQ
activities.
Generate and maintain validation documentation to cGMP standards, including:
Validation Plans
Protocols (IQ/OQ/PQ)
Final Reports
Review and approve validation protocols, deviations, reports, and supporting documentation.
Ensure all validation activities comply with internal procedures and regulatory requirements.
Collaborate with cross-functional teams to resolve validation issues and maintain compliance.
Required Experience & Skills
? Minimum
5 years
industry experience in
pharmaceuticals, medical devices, or diagnostics
? Strong expertise in:
Risk-based qualification
Commissioning & Qualification (C&Q)
IQ / OQ / PQ execution
PPQ (Process Performance Qualification)
Automation validation
? Hands-on experience generating and executing validation protocols
? Strong understanding of
FDA
,
EU cGMP
,
GAMP
and validation best practices
? Ability to write clear, compliant validation documentation
? Excellent coordination, communication, and cross-functional collaboration skills
Ideal Candidate
You are a detail-oriented validation professional who thrives in regulated environments, brings strong technical judgement, and can deliver high-quality validation outputs independently while working fully onsite.
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