Equipment Validation Engineer - Pharmaceutical
Reporting To: Sr. Manager, Engineering
- Responsible for designing and performing appropriate testing to verify that new and existing production equipment and utility systems are suitable for use in the commercial production of oral solid dosage (OSD) and powder pharmaceutical products.
- Prepare and execute detailed equipment qualification protocols (IQ/OQ/PQ) and summary reports to verify that both new and legacy equipment and critical utilities are installed, operate, and perform as designed and as per company and customer requirements.
- Prepare clear, concise SOPs for the setup, operation, cleaning and maintenance of equipment. Train personnel on SOPs as required.
- Prepare and execute packaging line engineering studies for specific products to develop acceptable ranges for critical process parameters (CPP’s).
- Create packaging line setup sheets containing results of engineering studies to aide mechanics in setup of equipment.
- Calibrate critical process control instrumentation (temperature controllers, pressure gauges/monitors, etc.). Create detailed calibration reports.
- Organize and maintain records for equipment including manuals, drawings, and calibration documentation.
- Prepare and execute temperature/humidity mapping studies of warehouse storage areas to verify that environmental conditions are acceptable for product storage (seasonal/as needed).
- Maintain databases for tracking completion of all aforementioned activities.
- Assist with writing deviations and corrective actions as needed.
- Visit vendor facilities for Factory Acceptance Testing (FAT) as needed.
- Serve as point of contact for engineering/equipment-related issues and inquiries.
- Other responsibilities as assigned by Senior Management
- Bachelor’s degree in Engineering (Mechanical, Electrical, or Industrial/Systems preferred) some work experience (either internship or full-time) in a similar role (equipment qualification, commissioning, test engineering, etc.) or Associate’s degree in Engineering Technology with at least three (3) years experience in a similar role will be considered
- Knowledge of FDA cGMPs and/or ISO quality system regulations preferred
- Experience with pharmaceutical manufacturing and packaging equipment and utilities (HVAC, USP water systems, compressed air systems) desired
- Excellent organizational skills, with strong verbal and written communication skills needed
- Must be analytical, detail-oriented and able to prioritize many projects at one time
- Ability to interact with all levels of personnel
- Stable employment history
- POSITION TITLE AND SALARY very flexible based on years of experience and level of expertise
- RECENT ENGINEERING GRADS WELCOME TO APPLY
CPC is offering a professional, stable work environment with excellent opportunity for career growth in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off, and company match 401(k) plan.Apply for the job »
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