SENIOR ASSOCIATE MANUFACTURING – NIGHTS
Posted on: 4 Sep 2021
West Greenwich, RI
Job Description
Responsibilities:
Lead manufacturing operations on the production floor.
Ensure all safety and compliance procedures are followed at all times.
Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
Serve as SME for functional area operations.
Provide training to manufacturing staff on process and equipment.
Own deviations and Corrective and Preventive Actions (CAPA)
Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas.
Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
Participate in the design, development, and implementation of processes in support of the manufacturing floor.
BASIC QUALIFICATIONS:
Master’s degree OR
Bachelor’s degree and 2 years of Manufacturing or Operations experience OR
Associate’s degree and 6 years of Manufacturing or Operations experience OR
High school diploma / GED and 8 years of Manufacturing or Operations experience
PREFERRED QUALIFICATIONS:
Bachelor’s degree in Science or Engineering
Knowledge of cell culture operations and bioreactors or purification operations including aseptic processing
Experience operating Single-use-Systems
Knowledge of DeltaV (for process control) and windows-based software
CFR and Regulatory knowledge
Mechanical aptitude with ability and expertise
Ability to independently collaborate with outside resources
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods and equipment for manufacturing area
Demonstrated technical writing capability
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Troubleshooting skills on process equipment
Ability to lead teams
Amgen Inc.
Oakland, CA
Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, and neuroscience. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta, a pegylated protein to treat cancer patients; Prolia to treat postmenopausal women with osteoporosis; Aranesp to treat anemia; Xgeva for skeletal-related events prevention; Sensipar/Mimpara products to treat sHPT in chronic kidney disease; and EPOGEN to treat a lower-than-normal number of red blood cells.
It also markets other products in various markets, including Kyprolis, Nplate, Vectibix, Repatha, NEUPOGEN, Parsabiv, Blincyto, Aimovig, Imlygic, Corlanor, Kanjintitm, and Amgevitatm. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. The company has collaborative agreements with Novartis; UCB; Bayer HealthCare Pharmaceuticals Inc.; and DaVita Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
-
IndustryManufacturing
-
No. of Employees21, 500
-
Website
-
Jobs Posted662
