Associate Manufacturing - AML 14 (Night Shift)

Amgen • Juncos, PR

1d • Onsite

About The Position

Join Amgen's mission to serve patients living with serious illnesses by pioneering biotech in the fight against tough diseases across Oncology, Inflammation, General Medicine, and Rare Disease. As an Associate Manufacturing professional, you will support formulation operations according to Standard Operating Procedures (SOPs), performing and supervising critical processes, executing routine protocols, and drafting/revising documents. You will also perform basic troubleshooting, assist in documentation review, and may participate in cross-functional teams. This role involves identifying, recommending, and implementing improvements related to routine functions within a Non-Standard Night Shift environment, and may include owning Deviations/CAPA's.

Requirements

• High school/GED and 2 years of manufacturing work experience
• OR Associate’s degree and 6 months of manufacturing work experience
• OR Bachelor's Degree

Nice To Haves

• Experience with Drug Product formulation manufacturing process
• Experience in cleaning a sterilization of portable or fixed tanks, buffer solutions preparation or formulations processes.
• Availability to Support Non-Standard Night Shift including rotative 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.

Responsibilities

• Conduct routine sanitization of equipment and manufacturing areas in compliance with established procedures and regulatory standards.
• Support validation activities, documentation review (e.g., 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 Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs), and safety protocols consistently—using reader-doer or similar methods when applicable.
• Use electronic systems such as SAP, Symphony, SCADA, or batch record platforms (training provided) to record activities, track materials, and verify production data accurately.
• Complete documentation in a timely, compliant manner, applying Good Documentation Practices (GDP) to ensure traceability and readiness for inspections or audits.
• Stay informed by reviewing SOPs regularly and asking questions when clarity is needed—supporting safe and accurate execution of tasks.
• Detect and respond to equipment or process deviations early, following SOPs and escalating issues to leads or support teams when appropriate.
• Support investigation or root-cause analysis efforts to help resolve process issues and improve performance.
• Work collaboratively with peers, leads, and trainers to meet expectations, solve problems, and foster a respectful, team-oriented work culture.
• Adapt to changing priorities and offer support to the team during downtime or as directed by your lead or supervisor to maintain operational flow.
• Participate in daily team meetings and use communication tools and production tracking systems to align your work with real-time production needs.
• Demonstrate commitment, flexibility, and attention to detail to complete tasks efficiently—especially within a dynamic, round-the-clock production environment.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees