Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.
Paragon Gene Therapy, in Baltimore, Harmans, Rockville, & Gaithersburg, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.
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.
Support changes through the provision of necessary validation documentation and change control activities.
Develop and support continuous improvement initiatives
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.
Experience and Education:
Bachelor or Master’s degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering.
1-3 years of experience in a validation role with some or all of it supporting equipment qualification and facilities commissioning activities.
Experience with process validation preferred.
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.