Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
The Senior Process Validation Engineer is responsible for qualifying cGMP manufacturing equipment cleaning, process validation and aseptic / sterile processes.
- Responsible for Cleaning Validation, Process Validation, and Aseptic Processing
- Generates, reviews, and approves qualification protocol(s), for various processes in the facility.
- Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.
- Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.
- Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
- Ensures the timely completion of all applicable validation documentation, including coordination of contractor activities.
- Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.
- Maintains the validation program for process qualification, aseptic processing, and cleaning verification activities.
- Provide SME level support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures.
- Participate in product failure investigations.
- Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.
- Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis and FMEA.
- B.S. in Engineering or Science discipline
- 5 or more years of validation experience in a GMP environment
- Experience leading a successful PPQ campaign is highly desirable
- Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays