Position Details
About this role
This role involves ensuring the compliance and validation of manufacturing and laboratory systems in a regulated environment, supporting quality assurance and regulatory adherence.
Key Responsibilities
- Lead equipment validation projects
- Perform gap analyses
- Ensure compliance with regulatory standards
- Maintain validated state of systems
- Collaborate with internal teams
Technical Overview
The technical scope includes cGMP, GXP, GAMP, SDLC, and validation of pharmaceutical and manufacturing systems, with a focus on regulatory compliance and documentation.
Ideal Candidate
The ideal candidate is a senior compliance engineer with at least 5 years of experience in FDA-regulated industries, knowledgeable in cGMP, GXP, GAMP, and validation processes, with strong documentation and regulatory compliance skills.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in FDA-regulated industries, No knowledge of cGMP or GXP, Inability to work in Indianapolis or remotely
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