Quality Assurance Cleaning Validation Engineer
Piper Clinical Solutions is seeking QA Validation Engineer for a bio-pharmaceutical company in Raleigh-Durham, North Carolina (NC). The Validation Engineer will be a key player in the identification of problems and the development of controls and systems to ensure compliance with regulatory requirements.
Responsibilities for the QA Validation Engineer:
- Develop and revise new and existing procedures in accordance to GMP compliance
- Coordinate and execute validation studies, writing protocols, and reports for equipment, utilities, cleaning and computer systems validation (CSV).
- Responsible for supporting CAPA’s, risk analysis, process validation and development, and other quality assessments
- Provide recommendations for policy change as well as equipment purchases and modifications
Qualifications for the QA Validation Engineer:
- Bachelor’s degree in science, engineering, or related field
- 5+ years of validation experience in a pharmaceutical or biotechnology industry
- Must have extensive cleaning validation experience
- Qualifying and validating GMP laboratory equipment, laboratory utilities, process equipment, computer systems, laboratory systems, etc.
- Experience working with 21 CFR and GAMP requirements
Compensation for the QA Validation Engineer:
- Determined by relevant professional experience and previous compensation history.
- Comprehensive benefits package: Healthcare, Dental, Vision, 401k, etc.
Send resumes to firstname.lastname@example.org