Bioprocessing Technician, Upstream Operations
1 week ago
POSITION SUMMARY
The Bioprocessing Technician, Upstream Operations, will carry out essential manufacturing tasks within GMP environments, focusing on fermentation and cell culture processes. This role involves adhering to established Standard Operating Procedures (SOPs) and maintaining batch records to ensure the production of high-quality biopharmaceutical products. Flexibility in work hours and the possibility of overtime may be required.
KEY RESPONSIBILITIES
- Conduct GMP manufacturing tasks in designated areas.
- Adhere to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and safety protocols to ensure product quality.
- Document quality-related events, including Incident Reports (IRs), Deviation Events (DEVs), and Out of Tolerance (OOT) occurrences.
- Initiate and manage Change Controls and MasterControl Document Change Controls (DCCs).
- Set up, operate, maintain, and sanitize upstream bioprocessing equipment.
- Exhibit proficient aseptic techniques.
- Perform basic troubleshooting of bioprocessing equipment.
- Carry out manual cleaning and sterilization of components and parts.
- Maintain detailed process documentation, including equipment logs and batch records, in accordance with good manufacturing documentation practices.
- Draft and update SOPs and batch records as necessary.
- Keep manufacturing SOP binders current.
- Address production challenges and escalate compliance issues to management.
QUALIFICATIONS
Education and Experience
- Bachelor's or advanced degree in life sciences or a related field, or equivalent education and experience.
- Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotechnology sector, or equivalent education and experience.
Knowledge, Skills, and Abilities:
- Preferred experience in cGMP manufacturing for biological products.
- Familiarity with upstream processes, including cell passaging, aseptic techniques, and operation of bioreactors, fermentors, and harvest filtration systems.
- Basic understanding of current biologics regulations and cGMP for drug substance operations.
- Proficient in Microsoft Word and Excel.
- Able to work safely with pressurized systems, steam, and corrosive chemicals.
- Demonstrated ability to follow and document procedures accurately.
- Detail-oriented with strong teamwork capabilities.
- Effective collaboration skills, with the ability to work across various functions and with internal stakeholders.
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