What You Will Achieve
- Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors/fermentors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids.
- Follow SOPs and batch records for unit operations.
- Supports equipment commissioning, qualification, and validation.
- Assists troubleshooting and resolution of equipment, automation, and process issues.
- Performs daily documentation review and data entry; identifies/communicates process and compliance concerns in real time.
- Participates in audits, as required.
- Assists SME for manufacturing operations for QTS investigations and CAPA implementations.
- Maintains assigned training.
- Supports Lean Manufacturing/Sustainability/Operational Excellence and continuous improvement.
- Escalates when operations, personnel safety, equipment functionality, supply, and/or quality compliance are at risk.
- Escalates need for work requests when facility/manufacturing equipment issues arise.
- Uses enterprise systems including SAP, LIMS, AMPS, PDOCS and/or QTS.
- Assists with cleaning, inventory, and maintaining a safe and GMP-compliant facility.
Here Is What You Need (Minimum Requirements)
- High School Diploma/GED with 2+ years relevant experience (or Associate with 0 years)
- Strong verbal/written communication; teamwork
- Proficiency using manufacturing equipment/tools
- Basic GMP understanding; ability to follow SOPs
- Structured problem-solving
- Basic computer skills for data entry/reporting
Bonus Points (Preferred Requirements)
- Pharmaceutical/biotech manufacturing experience
- Knowledge of regulatory requirements and quality systems
- Organizational detail, initiative, continuous improvement
- Adaptability; ability to interpret technical/analytical data