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Amgen Process Development Engineer - Industrial in Juncos, Puerto Rico

Are you looking for a significant new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Engineer - Industrial to join AML’s Process Development 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 role of the Process Development Engineer - Industrial is to improve drug product manufacturing operations including formulation, filling, inspection, device assembly and packaging for a varied number of products and volume mix in support of our Oral Dosage and Parenteral Drug Product facilities. The candidate will develop a deep understanding of the operations and become a subject matter expert of the process flows to simulate optimal process flows that can be implemented in operations. Utilize industrial engineering techniques to ensure capacity is in place to meet demand through the most effective and efficient manufacturing system. The role will provide support to new product introduction, improvement of existing processes and acquisition on new technologies. The input will serve for business cases of capital projects to obtain the funding required to implement initiatives. The position requires to have good documentation skills to write reports that can be used in regulatory audits.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Technical Responsibilities

  • Work in collaboration with Drug product manufacturing plants to find opportunities to improve efficiency and capacity to the current operations evaluating current and future demand forecast

  • Develop and validate computer models to perform capacity analysis and option analysis for new and existing processes

  • Develop process solutions to a variety of technical problems of moderate scope and complexity enabling new equipment and technology

  • Develop manufacturing implementation policies to maximize process area throughput, minimize work in progress and minimize operational costs.

  • Responsible to find opportunities to maximize use of headcount in operations.

  • Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured and personnel

  • Prepare business cases and lead implementation of projects assigned.

  • Develop business cases for new or modifications to existing systems, to determine feasibility based on business needs, including but not limited to demand, capacity, logistics, space, financial impact and head count

  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures.

  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables

  • Responsible for identifying, drive and lead continuous improvement opportunities and assist in prioritization of area project

  • Applies lean six sigma, operational excellence and continues improvement in assigned projects

  • Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components

  • Partner with internal resources to develop dashboards (e.g. Tableau, Spotfire, Smartsheet) for reporting with drill-down capabilities

  • Lead the implementation of Lean Six Sigma and Design for Six Sigma principles for all projects

  • Support the development of user requirements specifications for new systems

  • Support the commissioning and qualification of new and existing assets

  • Support the characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans

  • Provide support in investigations and the proposal and implementation of corrective actions related to investigations

General responsibilities:

  • Meet specific project team goals and timelines.

  • Develop project plans and strategies for implementation working with project managers and SMEs.

  • Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.

  • Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)

  • Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)

  • May represent the department on project teams under supervision of a senior scientific staff member.

  • May initiate productive collaborations within and outside of the department or company.

Basic education & experience

Master’s degree in Engineering

or

Bachelor’s degree in Engineering and 2 years of experience in GMP regulated industry

Preferred qualifications

Technical Skills

  • Experience performing time studies, capacity analyses, labor modeling and process modeling.

  • Demonstrated experience in OEE, Theory of Constraints, Lean Manufacturing and/or 6 Sigma is a plus

  • Subject Matter Expert in manufacturing process simulation packages

  • Knowledge on 3D drawing software

  • Analytical Problem solving and applied engineering

  • Experience in Lean manufacturing implementations

  • Knowledge on Six Sigma and/or Design for Six Sigma methodologies

  • Knowledge in statistics and statistical software (e.g. Minitab)

  • Ability to deal and manage change in a dynamic environment.

  • Experience with data diagnostics, discovery, modeling and visualization

  • Experience creating and collaborating in SharePoint, Box, Yammer, Teams, Tableau, Smartsheet, etc.

  • Working knowledge of pharmaceutical/biotech processes

  • Familiarity with documentation in a highly regulated environment

  • Ability to interpret and apply GMPs.

  • Ability to apply engineering science to production.

  • Able to develop solutions to routine technical problems of limited scope

General Skills

  • Field of Studies: Industrial Engineer

  • Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.

  • Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.

  • Fully bilingual in Spanish and English

  • Demonstrated strong problem solving and conflict resolution

  • Demonstrated leadership skills, initiative and self-motivation.

  • Excellent time and project management skills to deliver projects on time and budget.

  • Great teammate with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making

  • High quality and compliance mind set to work in a highly regulated GMP industry.

  • Computer literacy (Windows environment: Word, Excel, Power Point, Minitab

The Benefits

Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us passionate about 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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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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