Senior Associate Manufacturing - Nights

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Manufacturing - Nights

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What you will do

Let’s do this! Let’s change the world! In this vital role, under minimal supervision, you will perform and monitor critical processes, complete routine qualification and validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, deviations/CAPAs, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the area manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing their home department. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations. [top-line statement connecting primary position responsibility to employer brand].

• 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.

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule. This includes extra benefits such as receiving an added 15% shift differential, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding/training phase (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

Win

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 a teamplayer with these qualifications.

Basic Qualifications:

• High school/GED + 4 years manufacturing or operations work experience OR

• Associate’s + 2 years manufacturing or operations work experience OR

• Bachelor’s + 6 months manufacturing or operations work experience OR

• Master's

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

• Abili