CQV Process Support Engineer
CQV Process Support Engineer
Posted on :
02-10-2024
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Job Description
Title: CQV Process Support Engineer
Location: Holly Springs NC
Onsite
Key Responsibilities
- Provide CQV process support to clients that manufacture GMP products.
- Develop CQV planning doents to manage CQV projects.
- Generate and execute CQV protocols using Good Doentation Practices (GDPs).
- Investigate and resolve protocol exceptions or discrepancies.
- Develop technical reports and CQV summary reports.
- Read and verify facility and equipment drawings (e.g. P&IDs AF&IDs).
- Develop Standard Operating Procedures (SOPs) process workflows Validation Master Plans User Requirement Specifications and other regulatory support doentation.
- Participate in integrated delivery (EPCMV) project teams.
- Bachelors degree in Chemical or Mechanical Engineering or equivalent experience.
- CQV process engineering experience in the Life Sciences industry.
- Understanding of Good Manufacturing Practices (GMPs).
Ss
- Knowledge of US FDA (21 CFR) and EU EMEA regulations.
- Knowledge of industry guidance including:
- ISPE Baseline Guide 5 Commissioning and Qualification
- ISPE GAMP V A RiskBased Approach to Compliant GMP Computerized Systems
- ASTM E2500 Standard Guide for Specification Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- ISPE Guideline: Science and RiskBased Approach for the Delivery of Facilities Systems and Equipment 2011
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification 2011
Employment Type
Full Time
Key Skills
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