Manager, Validation

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, & 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 Validation Manager will work is responsible for managing the qualification of cGMP manufacturing equipment cleaning processes, manufacturing processes, analytical methods, and aseptic/sterile processes.

Key Responsibilities include but are not limited to:

Responsible for establishing and maintaining Paragon policy in the areas of 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.
System owner for internal audits, supplier quality, and continuous improvement.
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.
Serves as PV lead when interacting with clients and/or regulatory bodies.
Maintains the validation program for process qualification, aseptic processing, and cleaning verification activities.
Authors/maintains the cleaning verification master plan and policy.
Leads the regulatory defense of validation protocols and summary reports during audits and internal audits.
continuous improvement initiatives for the validation of cleaning, aseptic, and manufacturing processes.
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.
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.
Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis and FMEA.
Management of staff.
Budgetary input for organization, including preparation, maintenance, and re-forecasting.
Other duties as assigned.

Experience & Education:

Minimum of 7 to 10 years of experience in Biopharma manufacturing.
B.S. in Engineering or Science field.
3-5 years in a supervisory/management role.
Experience with leading a successful PPQ campaign is highly desirable.
Experience in designing and leading Aseptic Process Simulations is highly desirable.
Leading the design/execution of an equipment cleaning validation study, to include working knowledge of setting cleaning limits and swab recovery studies.

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.