Mfg 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
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), accurately complete process-associated documentation, make calculations and perform the physical tasks associated with bulk manufacturing
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.
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 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
- 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
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Discretionary Annual Bonus
- 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.