Associate Manufacturing – AML 14 (Night Shift)
Amgen, Juncos, Juncos, United States
Associate Manufacturing – AML 14 (Night Shift)
What you will do:
Support the formulation operations according to Standard Operating Procedures (SOPs). Perform and supervise critical processes, execute routine protocols, draft and revise documentation such as Manufacturing Procedures and SOPs, perform basic troubleshooting, review documentation, and support cross‑functional teams. Own Deviations/CAPA, recommend improvements in a Non‑Standard Night Shift environment.
Specific Responsibilities
Conduct routine sanitization of equipment and manufacturing areas in compliance with established procedures and regulatory standards.
Support validation activities and documentation review (batch records, audits) and basic troubleshooting.
Identify and recommend process improvements, collaborate with engineers, mechanics or leads for complex issues.
Monitor equipment, workspaces, and process outputs to confirm they meet safety, quality, and performance standards.
Follow SOPs, GMPs, and safety protocols consistently.
Use electronic systems such as SAP, Symphony, SCADA, or batch record platforms to record activities, track materials, and verify production data.
Complete documentation timely and comply with Good Documentation Practices to ensure traceability and readiness for inspections or audits.
Stay informed by reviewing SOPs regularly and asking questions when clarification is needed.
Detect and respond to equipment or process deviations early, follow SOPs, and escalated issues to leads or support teams when appropriate.
Support investigation or root‑cause analysis efforts to resolve process issues and improve performance.
Work collaboratively with peers, leads, and trainers to meet expectations and foster a respectful, team‑oriented work culture.
Adapt to changing priorities and offer support during downtime or as directed by leads or supervisors.
Participate in daily team meetings and use communication tools and production tracking systems to align work with real‑time production needs.
Demonstrate commitment, flexibility, and attention to detail to complete tasks efficiently in a dynamic night shift environment.
What we expect of you
High school/GED with 2 years manufacturing experience OR Associate’s degree with 6 months manufacturing experience OR Bachelor’s degree.
Preferred Qualifications
Experience with drug product formulation manufacturing process.
Experience in cleaning or sterilization of portable or fixed tanks, buffer solutions preparation or formulation processes.
Availability to support non‑standard night shift including rotational weekdays and weekends.
Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS.
Educational background in life sciences, biotechnology or engineering.
Experience working in a GMP regulated environment within the biotechnology, pharmaceutical or medical device industry.
Excellent communication, organization, attention to detail and technical writing skills.
Benefits
Comprehensive employee benefits package including retirement and savings plan with company contributions, group medical, dental & vision coverage, and life & disability insurance.
Discretionary annual bonus program, or sales‑based incentive plan for field sales representatives.
Stock‑based long‑term incentives.
Award‑winning time‑off plans and an annual site shutdown.
Flexible work models where possible.
Equal Opportunity Statement
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, disability status, or any other protected characteristic. We will provide reasonable accommodation for disability throughout the application and working process.
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What you will do:
Support the formulation operations according to Standard Operating Procedures (SOPs). Perform and supervise critical processes, execute routine protocols, draft and revise documentation such as Manufacturing Procedures and SOPs, perform basic troubleshooting, review documentation, and support cross‑functional teams. Own Deviations/CAPA, recommend improvements in a Non‑Standard Night Shift environment.
Specific Responsibilities
Conduct routine sanitization of equipment and manufacturing areas in compliance with established procedures and regulatory standards.
Support validation activities and documentation review (batch records, audits) and basic troubleshooting.
Identify and recommend process improvements, collaborate with engineers, mechanics or leads for complex issues.
Monitor equipment, workspaces, and process outputs to confirm they meet safety, quality, and performance standards.
Follow SOPs, GMPs, and safety protocols consistently.
Use electronic systems such as SAP, Symphony, SCADA, or batch record platforms to record activities, track materials, and verify production data.
Complete documentation timely and comply with Good Documentation Practices to ensure traceability and readiness for inspections or audits.
Stay informed by reviewing SOPs regularly and asking questions when clarification is needed.
Detect and respond to equipment or process deviations early, follow SOPs, and escalated issues to leads or support teams when appropriate.
Support investigation or root‑cause analysis efforts to resolve process issues and improve performance.
Work collaboratively with peers, leads, and trainers to meet expectations and foster a respectful, team‑oriented work culture.
Adapt to changing priorities and offer support during downtime or as directed by leads or supervisors.
Participate in daily team meetings and use communication tools and production tracking systems to align work with real‑time production needs.
Demonstrate commitment, flexibility, and attention to detail to complete tasks efficiently in a dynamic night shift environment.
What we expect of you
High school/GED with 2 years manufacturing experience OR Associate’s degree with 6 months manufacturing experience OR Bachelor’s degree.
Preferred Qualifications
Experience with drug product formulation manufacturing process.
Experience in cleaning or sterilization of portable or fixed tanks, buffer solutions preparation or formulation processes.
Availability to support non‑standard night shift including rotational weekdays and weekends.
Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS.
Educational background in life sciences, biotechnology or engineering.
Experience working in a GMP regulated environment within the biotechnology, pharmaceutical or medical device industry.
Excellent communication, organization, attention to detail and technical writing skills.
Benefits
Comprehensive employee benefits package including retirement and savings plan with company contributions, group medical, dental & vision coverage, and life & disability insurance.
Discretionary annual bonus program, or sales‑based incentive plan for field sales representatives.
Stock‑based long‑term incentives.
Award‑winning time‑off plans and an annual site shutdown.
Flexible work models where possible.
Equal Opportunity Statement
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, disability status, or any other protected characteristic. We will provide reasonable accommodation for disability throughout the application and working process.
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