Amgen Job Openings – Sr Mgr QA _ AML 1 Inspection and Packaging

Job Description:

Let’s do this. Let’s change the world! In this vital role you will lead the field support Engineering team in the I&P non-standard shift Drug Product Operations. Responsible for supervising, hiring, and developing staff. Ensuring operations uptime and activities are completed on time while maintaining safety, quality, and financial objectives. Specific responsibilities include but are not limited to:

Job Responsibilities:

• Management of contractors and vendors.
• May lead system ownership groups: providing adequate maintenance procedures, monitoring performance data, providing adequate training materials, and continuously improving systems.
• Crisis management, emergency response and decision making.
• Interacts with senior external personnel often requiring coordination between organizations.
• Liaison with engineering groups to provide support for the design, installation, start-up, and validation of facility, utilities and inspection and packaging equipment.
• Directly supervises staff and personnel mentoring & development.
• Ensure resources are allocated and well trained to support Inspection and Packaging day to day operations and strategic roadmap.
• Plan, prioritize, and coordinate work of a staff of engineers and/or technicians.
• Monitor Inspection and Packaging equipment uptime ensure prompt response to adverse tendencies and maintain uptime in the upper 90’s %.
• Perform the role of Functional area owner for the deviation process in Inspection and Packaging.
• Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
• Supervise, coordinate, and review work of a small staff of engineers and/or technical specialists on an ongoing basis.
• Represents the organization as the engineering and systems manager for IP.
• Ensure training programs are adequate for the personnel.
• Responsible for selection, training, evaluation, staff relations, and development of staff.
• May lead a maintenance organization responsible to keep inspection and packaging operation equipment operating efficiently and consistently.
• Established expertise in multiple areas of inspection and packaging operations.
• Guides the successful completion of programs or multiple projects.
• Conceive plans and conduct engineering investigations in areas of considerable scope and complexity.
• Interacts with peers in other Final Drug Product facilities in the network.

Job Requirements:

• 3+ years of GMP regulated industry experience
• Licensed Engineer (EIT or PE)
• Change management skills and site or facility wide knowledge
• Proficient English and Spanish communication skills
• Proficient in troubleshooting and problem solving
• Lean Six sigma experience and process improvement mentality
• Understands regulatory trends in industry. Some direct experience with FDA or equivalent regulatory body.
• 4+ years of experience leading technical teams
• Working knowledge of financial analysis tools.

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: General Business

Job Location: Juncos, PR

Application Deadline: N/A

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