Manufacturing Process Technician - Days
Amgen
Summary
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.
Job description
What you will do
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 cleaning, including Intermediate Bulk Containers (IBC's)
- CIP and SIP of BDS vessels
- Weigh and dispense of raw materials
- Operation and process monitoring of Delta-V recipes
- Sample collection, processing, storage and delivery
- Inventory management and reconciliation
- 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. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
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.
Requirements
- High school diploma or GED with 1 year of Manufacturing or Operations work or military experience, OR Associate's degree
- Ability to work a 12-hour rotating shift (7am-7pm, two-week rotation covering 7 days per week)
- Strict adherence to cGMP principles
- Strong attention to detail
- Ability to follow written procedures
- Strong communication skills
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement & Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.