What are the responsibilities and job description for the Senior Validation Engineer position at Technical Source?
Technical Source is seeking a Senior CQV Lead (Owner’s Rep) to support and manage an expansion to an existing bulk-drug substance Manufacturing site in NC. Execution will be complex as operations with the existing site cannot be interrupted. Demand for utilities and tie-ins, shutdowns, and interplays will require tight coordination between the CQV execution for the new project and existing operations.
Key Responsibilities:
- Someone who has led a team of CQV engineers.
- Proven experience as an Owners Rep or who has been a lead with an Engineering Services firm.
- Experience managing and communicating your clients' expectations with 3rd parties.
- Ensure there are no interruptions with the operations of the existing facility as expansion is taking place.
- Lead the CQV efforts for stainless steel process equipment, including skids, tanks, and mixing operations for buffers.
- Excellent communication skills.
- Document reviews and approvals. Ability to guide a team through their document review and approval process.
Required Qualifications:
- 10 years of experience with Purification and someone that can hit the ground running.
- Bachelor's degree in Engineering (Chemical, Mechanical, or related field)
- Experience with KNEAT software.
- Experience with Downstream operations, CIP Systems and Utilities
