Associate Manufacturing – Component Prep (Night Shift)

Amgen•Juncos, PR

About The Position

The Associate Manufacturing – Component Prep supports the manufacturing Formulation and Filling Facility at Amgen Manufacturing Limited in Puerto Rico. This role is part of a 24/7 operation and helps ensure safe and efficient production through equipment operation, procedural compliance, and teamwork. After training, the associate operates manufacturing equipment independently and performs production tasks using established procedures. The role includes operating specialized equipment such as autoclaves, parts washers, ultrasonic equipment, and a stopper processor system; monitoring equipment, workspaces, and outputs; recording and verifying production data in electronic systems; and completing compliant documentation in the Electronic Batch Record. The associate also performs product monitoring, sampling, and testing as part of cleaning activities, conducts basic troubleshooting, and escalates deviations or complex issues as appropriate. The position requires collaboration with peers, leads, trainers, engineers, and mechanics; participation in daily meetings; and flexibility to support changing production priorities and downtime needs. The job posting specifies a night shift and describes work in a dynamic, 24/7 production environment.

Requirements

One of the following education and experience combinations: a bachelor's degree; an associate degree plus 6 months of manufacturing work experience; or a high school diploma/GED plus 2 years of manufacturing work experience.

Nice To Haves

Educational background in life or natural science and/or engineering.
Minimal work experience in a GMP-regulated manufacturing environment.
Robust knowledge of Good Manufacturing Procedures and a proven record of successful execution.
Intermediate mathematics and problem-solving skills.
Proficiency in assembling, disassembling, operating, and understanding equipment according to procedures.
Knowledge of basic computer operations, including navigating MS Office, using email, and completing Computer Based Training.
Organizational skills and strong attention to detail.
Ability to follow written procedures, recognize and report malfunctions, and make equipment adjustments.
Good documentation skills.
Written and oral communication skills in English and Spanish.

Responsibilities

Operate manufacturing equipment independently after training and perform daily production tasks.
Operate specialized equipment, including autoclaves, parts washers, ultrasonic equipment, and the stopper processor system, according to established procedures.
Monitor equipment, workspaces, and outputs to ensure safety, quality, and performance standards are met.
Follow SOPs, cGMPs, safety protocols, and reader-doer or similar methods.
Record activities accurately and verify data using electronic systems such as SAP, PCS, and batch records.
Complete documentation promptly and compliantly, applying GDP within the Electronic Batch Record for traceability and audit readiness.
Review SOPs regularly and seek clarification when needed.
Identify and escalate equipment or process deviations according to SOPs.
Perform product monitoring, sampling, and testing as part of cleaning activities.
Troubleshoot basic issues and collaborate with engineers, mechanics, or leads on complex issues.
Collaborate with peers, leads, and trainers to meet goals and maintain a respectful, team-oriented culture.
Adapt to shifting priorities and assist during downtime or as directed to sustain workflow.
Participate in daily meetings and use communication tools to align with production needs.