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Amgen Sr Mgr Engineering AML - 14 in Juncos, Puerto Rico

Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Sr Manager Engineering to supports 14 Formulation and Filling Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Sr Manager Engineer role is responsible for leading and managing any one of the four functional areas of the engineering operations at the AML-14 Formulation and Aseptic Filling Facility. The functional areas are Utilities, Process Maintenance, Automation and Equipment Engineering (System Owners). These roles support the AML-14 manufacturing operations which includes the following areas: syringe filling, vial filling, formulation, component preparation, dispensing, thawing and environmental control. The role will also support the other engineering functional areas as required and other AML-14 initiatives like capital and departmental project teams, MES / EBR team, Quality, Process Development, Validations, IS, Regulatory and so on. This role is crucial for AML-14’s success, it is a key contributor in AML-14 Formulation and Aseptic Filling Facility daily operation and is considered part of the AML-14 Leadership Team.

The department

The AML-14 Facility is the home of best-in-class, multi-product Drug Product Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO

Technical

  • Manage all aspects the engineering functional area that provides technical, project, emergency response, troubleshooting and maintenance support for relevant equipment and/or systems

  • Lead the relevant functional area team to achieve plant goals and objectives

  • Resolve engineering, manufacturing and production issues with plant manufacturing staff and other supporting teams

  • Ensure relevant equipment / systems reliability and maintenance / repair is properly executed accordingly

  • Ensure consistent global engineering and operational practices are implemented

  • Ensure timely maintenance and availability of relevant equipment / systems

  • Explain complex equipment / systems intervention exercises and potential impact to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.)

  • Ensure functional area has the ability to internally manage it’s own Deviations, Change Control, CAPAs, EVs, ARMS and CDOCS documents (Quality System records & documents)

  • Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, …) that are owned by the functional area

  • Support the plant in the project approval, prioritization and implementation process

  • Develop functional area metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.

  • Maintain an environment that promotes functional area flexibility, consistent engineering practices, and efficient operations, which prepare us for current and future production demands

  • Provide technical direction to the team

  • Provide on-the-floor & hands–on support in complex troubleshooting exercises

Planning

  • Lead in the development of Engineering’s long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals

  • Ensure the coordination and goal alignment of functional area and plant production operations

  • Establish and communicate relevant equipment / systems goals and objectives consistent with the plant business strategy

  • Lead the development of Long-Range Planning (LRP) to maintain the highest level of support and enhance operations productivity

  • Develop, control, maintain, track, justify and stay within the functional area budget

Support Functions

  • Collaborate with and serve as department liaison to support other organizations (Manufacturing, QA, F&E, PD, IS, Spare Parts / Central Inventory, HR, etc.)

  • Resolve issues between manufacturing, quality and maintenance organizations

Compliance

  • Ensure relevant equipment / systems practices (processes & methods) and policies comply with external regulatory requirements and internal corporate and site guidelines and procedures

  • Connect with Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance

  • Develop, approve, establish and ensure practices and policies are consistent

  • Represent functional area in regulatory audits

  • Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area

Staff

  • Coach, mentor and ensure the development of supervisors and staff

  • Partner with HR to recruit, retain and empower staff

  • Ensure an ongoing organizational structure capable of adapting to changing business needs

  • Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs

  • Ensure functional area staff exemplifies the Amgen Values & Behaviors

  • Ensure an executable Succession Plan is in place for the relevant functional area

Basic Qualifications and Experience

Doctorate degree in Science, Technology or Engineering and 2 years of manufacturing equipment maintenance experience

or

Master’s degree in Science, Technology or Engineering and 6 years of manufacturing equipment maintenance experience

or

Bachelor’s degree in Science, Technology or Engineering and 8 years of manufacturing equipment maintenance experience

2 years of managerial experience managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources

Preferred Qualifications

  • Experience with Drug Product manufacturing technologies / equipment, specifically aseptic filling equipment and isolators

  • Knowledge of conflict resolution and negotiating skills

  • Ability to partner with other departments / functions / areas

  • Analytical problem solving

  • Considerable organizational skills

  • Experience in coaching, mentoring and counseling

  • Ability to deal with and manage fast and constant change

  • Ability to set goals

  • Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately

  • Customer satisfaction mentality

  • Flexibility to support off shift, weekend and holiday work

  • Ample knowledge of cGMP Regulations around Sterile Product Manufacturing and other relevant area regulatory requirements

  • Proven ability to maintain an environment and culture of operational excellence and continuous improvement

  • Proven experience implementing a continuous improvement program based on performance monitoring through KPIs

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.​

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