37 минут назад
Validation Engineer (cGMP)
60 966 - 85 694$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Validation Engineer (cGMP/Equipment Validation): Executing commissioning, qualification, requalification, and validation studies for plant equipment and systems with an accent on cGMP compliance, controlled-area requirements, and accurate validation reporting. Focus on programming analytical instruments, analyzing qualification data, investigating deviations, and defining corrective and preventive actions.
Location: Wilson, NC, United States; onsite work with periodic weekend and off-shift hours
Salary: $60,966–$85,694 per year
What you will do
- Schedule and execute equipment commissioning, qualification, and requalification activities according to SOPs.
- Prepare validation protocols, coordinate testing with functional groups, evaluate results, and prepare final reports.
- Program and operate analytical instruments, including temperature and humidity dataloggers, for controlled-environment qualification.
- Support improvements to validation programs in line with cGMPs and industry standards.
- Participate in teams specifying, installing, validating, troubleshooting, and maintaining plant systems and equipment.
- Investigate validation deviations, identify root causes, and define corrective and preventive actions.
Requirements
- Must work at the Wilson, NC plant and periodically cover weekends and off-shift hours.
- Comprehensive understanding of cGMP requirements.
- Ability to become certified for entry into controlled areas, including Grade D, C, and up to B/A areas.
- Ability to write clear, concise, and accurate reports and record data accurately.
- Basic understanding of statistical analysis.
Culture & Benefits
- Full-time employment with a comprehensive benefits package.
- 401(k) plan with company contributions.
- Paid vacation, holidays, and personal days.
- Medical, prescription drug, dental, and vision coverage.
- Life insurance, disability coverage, employee assistance program, and wellness program.
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