Process Validation Engineer

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 Process Validation Engineer is responsible for qualifying cGMP manufacturing equipment cleaning, process validation, and aseptic/sterile processes.

Key Responsibilities include but are not limited to:

• Generates qualification protocol(s), for various 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 process requirements.
• Support the maintenance of the validation program for process qualification, aseptic processing, and cleaning verification activities.
• Design/execute studies to determine clean and dirty hold times for all multi-use product contact manufacturing equipment.
• Support changes through the provision of necessary validation documentation and change control activities.
• Develop and support continuous improvement initiatives for the validation of cleaning, aseptic, and manufacturing processes
• 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 process failures.
• Collect and analyze data to make data driven recommendations/decisions
• Participate in process failure investigations.
• Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Process Development, 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.
• Participates in gap analysis, risk analysis and FMEA activities.

Experience & Education:

• B.S. in Life Science field required. Chemical / BioChemical or Biomedical Engineering preferred.
• Minimum of 2 years of experience process validation supporting biologic products in a GMP environment required
• Experience with executing a successful PPQ campaign is highly desirable
• Experience in designing and/or performing Aseptic Process Simulations is highly desirable
• Experience with design and execution of cleaning validation / verification studies is highly desirable.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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