Associate Manufacturing – Downstream - Nights (Multiple Positions)
Amgen
5 hours ago
On-site
Holly Springs, NC
Operations
Associate Manufacturing – Downstream - Nights (Multiple Positions)
What You Will Do
- Work a 12-hour 2-2-3 schedule from 5:45pm to 6:15am supporting critical 24/7 manufacturing operations.
- Perform downstream manufacturing operations in the cGMP (Current Good Manufacturing Practices) drug substance area.
- Support all floor operations in accordance with cGMP practices, including working assigned shifts as scheduled (including inclement weather, some holidays, and requested overtime).
Compliance
- Complete work per established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Assure proper gowning and aseptic techniques are always followed.
Process/Equipment/Facilities
- Perform hands-on downstream biotech operations (e.g., Column Chromatography, Tangential Flow Filtration), including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
- Run and monitor critical process tasks per assigned procedures.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]).
- Complete washroom activities: cleaning equipment used in production (small to large scale).
- Initiate and own manufacturing related process deviations.
- Identify and escalate issues/concerns related to daily routine process and tasks (may engage with team on solutions).
- Perform documentation for assigned functions (e.g., equipment logs, EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) to complete production activities.
- Maintain an organized, clean, and workable space.
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience, OR
- Associate’s Degree + 6 months manufacturing and/or other regulated environment experience, OR
- Bachelor’s Degree.
Preferred Qualifications
- Completion of NC BioWorks Certification Program.
- Experience in a regulated industry such as biotechnology or pharmaceutical.
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office skills; knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
- Desire and drive to learn and grow understanding of operations and processes.
Benefits
- In addition to base salary, competitive and comprehensive Total Rewards Plans aligned with local industry standards.
Application Instructions
- Apply now at careers.amgen.com.
What You Will Do
- Work a 12-hour 2-2-3 schedule from 5:45pm to 6:15am supporting critical 24/7 manufacturing operations.
- Perform downstream manufacturing operations in the cGMP (Current Good Manufacturing Practices) drug substance area.
- Support all floor operations in accordance with cGMP practices, including working assigned shifts as scheduled (including inclement weather, some holidays, and requested overtime).
Compliance
- Complete work per established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Assure proper gowning and aseptic techniques are always followed.
Process/Equipment/Facilities
- Perform hands-on downstream biotech operations (e.g., Column Chromatography, Tangential Flow Filtration), including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
- Run and monitor critical process tasks per assigned procedures.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]).
- Complete washroom activities: cleaning equipment used in production (small to large scale).
- Initiate and own manufacturing related process deviations.
- Identify and escalate issues/concerns related to daily routine process and tasks (may engage with team on solutions).
- Perform documentation for assigned functions (e.g., equipment logs, EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) to complete production activities.
- Maintain an organized, clean, and workable space.
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience, OR
- Associate’s Degree + 6 months manufacturing and/or other regulated environment experience, OR
- Bachelor’s Degree.
Preferred Qualifications
- Completion of NC BioWorks Certification Program.
- Experience in a regulated industry such as biotechnology or pharmaceutical.
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office skills; knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
- Desire and drive to learn and grow understanding of operations and processes.
Benefits
- In addition to base salary, competitive and comprehensive Total Rewards Plans aligned with local industry standards.
Application Instructions
- Apply now at careers.amgen.com.