Mfg Process Technician

Amgen SA; West Greenwich, Northern (RI, KY); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Amgen is seeking a Manufacturing Process Technician to join our days shift. You will perform bulk manufacturing tasks in aseptic and non-aseptic environments according to SOPs and batch records, with a 12-hour shift pattern and a two-week rotation.

The role requires adherence to cGMPs and precise documentation, with opportunities to grow within a supportive, award-winning culture focused on patient care.

Qualifications

• High school/GED + 1 year of Manufacturing or Operations work or military experience.
• Associate's degree (preferred).
• Experience in a GMP or other regulated environment is advantageous.
• GMP principles knowledge is beneficial.
• Drug substance manufacturing experience is a plus.
• Ability to stand or sit for extended periods.

Responsibilities

• Equipment and parts cleaning using manual and automated methods and equipment.
• Set up and breakdown of single use materials.
• Weigh and dispense of raw materials.
• Operation and process monitoring of clean systems, autoclaves, and processing equipment.
• Sample collection, processing, storage and delivery.
• Product and component reconciliation.
• Solution preparation and transfer.
• Materials handling, weighing and dispensing, power industrial vehicle operation.
• Document process tasks in electronic batch records.

Education

Associate's degree

High school/GED

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Manufacturing Process Technician - Days

What you will do

Let’s do this! Let’s change the world! In this vital role you will routinely perform simple to moderately complex processes according to Standard Operating Procedure and Batch Records. Generally, this will include all aspects associated with bulk manufacturing in aseptic and non-aseptic environments.

Responsibilities:

• Equipment and parts cleaning using manual and automated methods and equipment

• Set up and breakdown of single use materials

• Weigh and dispense of raw materials

• Operation and process monitoring of clean systems, autoclaves, and processing equipment

• Sample collection, processing, storage and delivery

• Product and component reconciliation

• Solution preparation and transfer

• Materials handling, weighing and dispensing, power industrial vehicle operation

• Strict adherence to current Good Manufacturing Practices (cGMP's), responsible to accurately complete process-associated documentation, make calculations and perform the physical tasks associated with bulk manufacturing and other duties as assigned.

You will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7am-7pm with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an excellent teammate with these qualifications.

Basic Qualifications:

• High school/GED + 1 year of Manufacturing or Operations work or military experience OR

• Associate's degree

Preferred Qualifications:

• Experience in a GMP/ other regulated environment.

• Demonstrated knowledge of GMP principles.

• Drug substance manufacturing experience.

• Ability to stand or sit for extended periods of time.

• Ability to maintain focus during repetitious tasks over the course of a shift.

• Ability to assemble, disassemble, operate and understand simple to moderately complex equipment per procedures.

• Basic understanding of measurements, calculations and the metric system.

• Ability to work effectively in an individual and team setting.

• Ability to document process tasks in electronic batch records.

• Coachable, ability to take coaching/critique and show learned/measurable improvement.

• Capacity to follow written procedures, recognize and report malfunctions.

• Strong communication skills.

• Ability to perform assignments with a high degree of focus/attention to detail.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• 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

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.