Associate Manufacturing - Component Prep (Night Shift)

Amgen; Puerto Rico; On-site; USD 42,000 - 65,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental & vision coverage

Bonuses

Job summary

Amgen's Puerto Rico facility is seeking an Associate Manufacturing - Component Prep for night shift. You will support Formulation and Filling operations, operate equipment, ensure safety and quality, and document activities in accordance with cGMPs.

The role requires the ability to work 24x7 shifts, familiarity with SOPs, and strong documentation skills in English and Spanish. Collaboration with engineers and leads is essential for maintaining production throughput.

Qualifications

• Bilingual communication in English and Spanish is preferred.
• Strong documentation and data-verification skills.
• Good numerical and problem-solving abilities.
• Ability to follow written procedures and SOPs.

Responsibilities

• Operate manufacturing equipment independently post-training and execute daily production tasks.
• Handle equipment such as Autoclaves, Parts Washers, and Stopper Processors per procedures.
• Monitor safety, quality, and performance standards across outputs and spaces.
• Maintain compliance with SOPs, cGMPs, and safety protocols.
• Record activities and verify data using electronic systems (SAP, PCS, batch records).
• Complete documentation promptly for GDP traceability and audit readiness in the EBR.
• Review SOPs regularly and seek clarification when needed.
• Identify and escalate equipment or process deviations.
• Perform monitoring, sampling, and basic product testing during cleanings.
• Collaborate with engineers, mechanics, and leads for complex issues.

Skills

Bilingual English/Spanish

Education

Bachelor's degree

Associate's + 6 months Manufacturing

High school/GED + 2 years Manufacturing

Tools

MS Office

Job description

Career Category
Manufacturing
Job Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

ASSOCIATE MANUFACTURING - COMPONENT PREP (NIGHT SHIFT)

What you will do

Let's do this. Let's change the world. In this vital role you will support the manufacturing Formulation and Filling Facility at Amgen Manufacturing Limited in Puerto Rico. You'll be part of a 24x7 operation, ensuring safe and efficient production through equipment operation, procedural compliance, and teamwork-on any shift, any day, where your contribution makes a difference.

• Operate manufacturing equipment independently post-training, ensuring consistent execution of daily production tasks.
• Conduct operations on specialized equipment (Autoclaves, Parts Washers, Ultrasonic and Stopper Processor System etc ) per established procedures to maintain quality and compliance.
• Monitor equipment, workspaces, and outputs to ensure safety, quality, and performance standards are met.
• Adhere to SOPs, cGMPs, and safety protocols using reader-doer or similar methods.
• Accurately record activities and verify data using electronic systems (e.g., SAP, PCS, batch records).
• Complete documentation promptly and compliantly, applying GDP for traceability and audit readiness within the Electronic Batch Record (EBR)
• Review SOPs regularly and seek clarification when needed to ensure safe and accurate task execution.
• Identify and escalation equipment or process deviations per SOPs.
• Perform monitoring, sampling, testing of the product as part of the cleanings.
• Conduct basic troubleshooting and collaborate with engineers, mechanics, or leads for 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.
• Demonstrate commitment, flexibility, and attention to detail in a dynamic, 24/7 production environment.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Associate Manufacturing professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

• Bachelor's Degree OR
• Associate's + 6 months of Manufacturing work experience OR
• High school/GED + 2 years of Manufacturing work experience

Preferred Qualifications:

• Educational background in Life/Natural Science and/or Engineering
• Minimal work experience in a manufacturing GMP regulated environment
• Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
• Intermediate Mathematics and problem-solving skills.
• Proficient performing assembling disassembling, operating and understanding equipment per procedures.
• Knowledge with basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
• Organization skills and talent to perform assignments with a high degree of attention to detail.
• Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.
• Good documentation skills.
• Written and oral communication skills in English and Spanish.

What you can expect of us

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

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 a