Paragon Bioservices, Inc. (PBI) is a growing bio pharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
The Sr. Validation Engineer will work in an FDA regulated clean room environment, this position is responsible for validation bio process equipment and GMP utilities.
- Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility.
- Oversees the timely completion of all validation documentation, including coordination of contractor activities.
- Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable.
- May interact with clients on equipment/process requirements.
- Support the maintenance of the validation program for facilities and equipment.
- Support changes through the provision of necessary validation documentation and change control activities.
- Support the regulatory defense of validation protocols and summary reports during audits and internal audits.
- Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to equipment failures. Collect and analyze data to make data driven recommendations/decisions
- Participate in equipment failure investigations
- Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality and Facilities Engineering
- Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies
- Ability and willingness to work in a fast-paced environment
- 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.
Education & Experience:
- B.S. in Engineering or Science field
- Minimum of 5 - 7 years of experience in biopharma manufacturing
- At least 2 years direct experience in the validation of fermenters and autoclaves
- Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable
- Working knowledge of Kaye/Amphenol datalogging equipment (Validator, AVS, ValProbe)
Requisition ID : 1043