BioSpace
Associate Manufacturing (Day Shift)
BioSpace, Holly Springs, North Carolina, United States, 27540
Associate Manufacturing (Day Shift)
You’ve worked hard and are ready to take the next step in your career. Join Amgen’s newest drug substance manufacturing plant – the FleX Batch facility – which combines disposable technology with stainless‑steel equipment for flexible operations and sustainability.
What You Will Do
Complete work in accordance with cGMP SOPs, MPs, JHAs, CFR, and strict adherence to safety and compliance.
Perform gowning, aseptic techniques, and maintain a clean environment.
Operate, set‑up, clean, sanitise and monitor equipment and assigned area.
Run and monitor critical process tasks per assigned procedures.
Conduct in‑process sampling, operate analytical equipment, and complete electronic batch record (EBR) documentation.
Handle washroom activities and equipment cleaning for small to large scale production.
Identify and report issues; engage with the team on solutions.
Perform documentation for assigned functions, including equipment logs and EBRs.
Collaborate with QA/QC, Facilities & Engineering, PPIC, Process Development, Regulatory, and other cross‑functional teams.
Maintain an organized, clean workspace.
Schedule: 10‑hour shift Mon‑Fri 6am‑4pm; transition to 12‑hour shift and alternate weekends as business needs dictate.
What We Expect Of You Basic Qualifications
High School/GED + 2 years manufacturing or regulated environment experience.
Associate Degree + 6 months manufacturing or regulated environment experience.
Bachelor’s Degree.
Preferred Qualifications
Completion of NC BioWork Certificate Program.
Experience in a regulated industry such as biotechnology or pharmaceutical.
Basic understanding and experience in a cGMP manufacturing facility.
Excellent verbal and written communication.
Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
Demonstrated drive to learn and grow operations and processes.
What You Can Expect Of Us
Salary range posted; actual salary varies by skills, experience, and qualifications.
Comprehensive benefits package: retirement and savings plan with generous company contributions, group medical, dental, vision coverage, life and disability insurance, flexible spending accounts.
Discretionary annual bonus program (sales‑based incentive plan for field sales) and stock‑based long‑term incentives.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements where possible.
No relocation assistance provided for these positions.
Location: Holly Springs, NC.
Apply now for a career that defies imagination.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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What You Will Do
Complete work in accordance with cGMP SOPs, MPs, JHAs, CFR, and strict adherence to safety and compliance.
Perform gowning, aseptic techniques, and maintain a clean environment.
Operate, set‑up, clean, sanitise and monitor equipment and assigned area.
Run and monitor critical process tasks per assigned procedures.
Conduct in‑process sampling, operate analytical equipment, and complete electronic batch record (EBR) documentation.
Handle washroom activities and equipment cleaning for small to large scale production.
Identify and report issues; engage with the team on solutions.
Perform documentation for assigned functions, including equipment logs and EBRs.
Collaborate with QA/QC, Facilities & Engineering, PPIC, Process Development, Regulatory, and other cross‑functional teams.
Maintain an organized, clean workspace.
Schedule: 10‑hour shift Mon‑Fri 6am‑4pm; transition to 12‑hour shift and alternate weekends as business needs dictate.
What We Expect Of You Basic Qualifications
High School/GED + 2 years manufacturing or regulated environment experience.
Associate Degree + 6 months manufacturing or regulated environment experience.
Bachelor’s Degree.
Preferred Qualifications
Completion of NC BioWork Certificate Program.
Experience in a regulated industry such as biotechnology or pharmaceutical.
Basic understanding and experience in a cGMP manufacturing facility.
Excellent verbal and written communication.
Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
Demonstrated drive to learn and grow operations and processes.
What You Can Expect Of Us
Salary range posted; actual salary varies by skills, experience, and qualifications.
Comprehensive benefits package: retirement and savings plan with generous company contributions, group medical, dental, vision coverage, life and disability insurance, flexible spending accounts.
Discretionary annual bonus program (sales‑based incentive plan for field sales) and stock‑based long‑term incentives.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements where possible.
No relocation assistance provided for these positions.
Location: Holly Springs, NC.
Apply now for a career that defies imagination.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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