Manufacturing Associate I - GMP Bioprocess
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical 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 Manufacturing Associate performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
• Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
• Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
• Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s
• Performs the weighing, dispensing of raw materials for media and buffers
• Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product.
• Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
• Dispensing, labeling, transfer/staging of raw materials and parts
• Assembly/disassembly, cleaning and sterilization of components, parts and equipment
• Maintaining equipment, area and cleaning logbooks
• Cleaning sanitizing production rooms and equipment
• Stocking production and cleaning supplies
• May author/ review/improve SOP’s, batch records, protocols and technical reports
• Actively participates in training activities, managing their individual training plan. Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
Skills & Behaviors:
• Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
• Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
• cGMP: Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
• Possess excellent written and oral communication skills.
• Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
• Possesses a basic understanding of the scientific theory of biologics manufacturing:
understands basic biotechnology processing - purpose of major unit operations and microbial control concepts
• Actively pursues learning of required skills, new skills, and new equipment
• Understand routine procedures upon which they have been trained.
• Possesses basic equipment understanding, including understanding equipment function and application.
• Proficient in MS Office and related PC skills
• Must have the ability to work an available set shift. There will be times when overtime is required.
• High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
• Associate’s Degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable, OR
• Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience