Associate Manufacturing – Downstream - Days (Multiple Positions)
Amgen
5 hours ago
On-site
Holly Springs, NC
Operations
Associate Manufacturing – Downstream - Days (Multiple Positions)
What You Will Do
- Support 24/7 downstream manufacturing operations; work a 12-hour 2-2-3 schedule (5:45am–6:15pm)
- Perform cGMP drug substance manufacturing operations on the floor
- Support all floor operations in accordance with cGMP practices
- Work assigned 12-hour shifts, including during inclement weather, some holidays, and requested overtime
Compliance
- Complete work in accordance with cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance
- Ensure proper gowning and aseptic techniques are followed
Process/Equipment/Facilities
- Perform hands-on downstream bioprocess 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; help engage on potential solutions
- Perform documentation for assigned functions (e.g., equipment logs, EBRs)
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, etc.) to complete production activities
- Maintain an organized, clean, workable space
What We Expect Of You
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 (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
- Total Rewards Plans (competitive and comprehensive) aligned with local industry standards
Application Instructions
- Apply now (careers.amgen.com)
What You Will Do
- Support 24/7 downstream manufacturing operations; work a 12-hour 2-2-3 schedule (5:45am–6:15pm)
- Perform cGMP drug substance manufacturing operations on the floor
- Support all floor operations in accordance with cGMP practices
- Work assigned 12-hour shifts, including during inclement weather, some holidays, and requested overtime
Compliance
- Complete work in accordance with cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance
- Ensure proper gowning and aseptic techniques are followed
Process/Equipment/Facilities
- Perform hands-on downstream bioprocess 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; help engage on potential solutions
- Perform documentation for assigned functions (e.g., equipment logs, EBRs)
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, etc.) to complete production activities
- Maintain an organized, clean, workable space
What We Expect Of You
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 (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
- Total Rewards Plans (competitive and comprehensive) aligned with local industry standards
Application Instructions
- Apply now (careers.amgen.com)