Validation Engineer (CQV)
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Job Location:
Lexington, KY - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Title: Validation Engineer (CQV)
Location: Lexington KY Onsite
Duration: Long term
Positions: 3
Job Summary
We are seeking a Validation Engineer to support Commissioning Qualification and Validation (CQV) activities for utilities process equipment and process validation. This is a client-facing role supporting site execution and documentation working within an established project team and reporting to a Compli Project Lead.
Key Responsibilities
Execute CQV activities for utilities process equipment and process validation in a GMP environment
Develop and complete CQV lifecycle documentation including URS/FRS risk assessments protocols summary reports deviations and trace matrices
Perform protocol execution and documentation for commissioning and qualification (as applicable) including data collection and review
Reconcile and verify qualification data investigate discrepancies and support deviation documentation and closure
Ensure deliverables are completed on schedule and provide accurate status updates to the project lead
Collaborate with cross-functional stakeholders vendors and client representatives as needed
Maintain compliance with site procedures safety requirements and applicable regulatory expectations
Required Qualifications
Minimum 5 years of hands-on experience in Commissioning Qualification and Validation (CQV) of utilities process equipment and process validation
Strong experience authoring and executing CQV lifecycle documents (URS/FRS risk assessments protocols summary reports deviations trace matrices)
Excellent verbal communication and technical writing skills
Ability to work to project schedules and manage deliverables with timely accurate reporting
Professional client-facing demeanor and strong interpersonal skills
Strong team player with experience working under a project lead structure
Preferred / Equipment Experience
CQV experience with one or more of the following: formulation vessels non-sterile nasal spray fill lines nasal sprayer assembly lines inspection equipment packaging equipment thermoforming equipment autoclaves
Thanks & Regards
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
