Commissioning & Qualification Documentation Lead
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-05-09
Listing for:
Stark Pharma
Full Time
position Listed on 2026-05-09
Job specializations:
-
Engineering
Quality Engineering, Pharma Engineer, Process Engineer, Validation Engineer
Job Description & How to Apply Below
Overview
The Commissioning & Qualification (C&Q) Documentation Lead is responsible for developing, authoring, and managing commissioning and qualification documentation in support of GMP-regulated projects.
Position details- Location:
Lebanon, IN - Contract Duration: 3-5 years
- Onsite: 4 days/week
- Required
- Firm understanding of writing documentation from scratch; draft, write and develop CLIAs (change controls) for C&Q;
URS experience - GMP/Pharma manufacturing
- Negotiation with external vendors and internal stakeholders
- Ability to effectively work with other teams
- Capex experience/large projects; ability to manage multiple priorities
- Independently draft, write, and develop commissioning and qualification documentation from initial concept through final approval, including protocols, reports, and supporting records
- Author and manage CLIAs (change controls) related to commissioning and qualification activities, ensuring alignment with site procedures and regulatory expectations
- Lead negotiations and technical discussions with external vendors to resolve documentation, scope, and execution-related issues
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