Manufacturing Associate I

at  Amgen

QUALIFICATIONS

• Bachelor’s Degree in Science or Engineering and 2 years of directly related experience OR
• Associate’s Degree in Science or Engineering and 4 years of directly related experience OR
• High School Diploma in Science or Engineering / GED and 6 years of directly related experience
• 1 year of experience in regulated environment
• Experience and basic troubleshooting skills with laboratory and process equipment
• Experience with Emerson DeltaV, OSI PI, LIMS, TrackWise
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Basic statistical mathematical skills
• Ability to organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Technical writing capabilities
• Proficient presentation and facilitation skills
• Detail oriented as well as flexible and adaptable to changing priorities and requirements
• Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training (CBT)
• Mechanical ability/expertise
• Understanding of analytical methods
• Ability and willingness to work any shift in support of operations that may include 24/7

WHAT YOU WILL DO

Main Responsibilities:

• Under general supervision, the manufacturing associate will support daily production requirements throughout the facility.
• Operations, maintenance and analytical testing will be performed according to Standard Operating Procedures (SOPs) and Job Plans, as required.
• The Associate Manufacturing will perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports.
• They will perform basic troubleshooting and assist in the review of documentation for assigned functions.
• The Associate Manufacturing may participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and may identify, recommend and implement improvements related to routine functions.
• After training is completed this position will be required to work on a rotational overnight shift.