Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices 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 Manufacturing Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.
Must be willing to work overtime or shift work as required.
Key Responsibilities include but are not limited to:
Initiates Quality Records and conducts deviation investigations that meeting both Industry and Paragon expectations
Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
Develops, executes and oversees CAPAs
Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
Supports Tech transfer and process monitoring support as needed
Works with the team to monitor critical process parameters
Revision and management of manufacturing documents such as Batch Records and SOPs
Leads or supports Continuous Improvement projects
Conducts data gathering, trending, and data presentation as needed to support investigations
Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
Education & Experience:
Bachelor's degree in a science or engineering field and 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
Previous experience in process deviation investigations and remediation
Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget
Excellent communication and technical writing skills
Ability to support and/or lead system troubleshooting efforts
Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
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.