This position is responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical faciality and utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen/argon consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products.
- Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Pharmaceutical facility and utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen.
- Participate in Engineering, Qualification and Validation efforts within manufacturing, and facility support systems. Support development and enhancement of Equipment Facility and Utility qualification programs federal and state agencies, and applicable global health authorities.
- Participate in development of risk based, quality driven procedures and practices with respect to engineering, qualification and validation.
- Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for the site.
- Participate in the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.
- Assist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments.
- Support the change control program with respect to facility, and equipment changes. Support the Information Technology change control program for computerized systems.
- Support the investigations program with respect to engineering, and qualification, related investigations, including trending and corrective and/or preventative actions.
- Perform technical review of qualification related documentation. Provide training/guidance to Quality, Maintenance/Engineering, Manufacturing, and Laboratory personnel on relevant policies and SOPs.
- Bachelor’s Degree in Engineering, Life Sciences or related discipline, with a minimum of 3 years of experience
- Knowledge of current Good Manufacturing Practice (cGMPs)
- A background knowledge in pharmaceutical science or engineering, and equipment/system validation