Principal Manufacturing Systems Engineer - Amgen PR Project Delivery Lead

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Manufacturing Systems Engineer - Amgen Puerto Rico Project Delivery Lead

Does the thought of supporting projects to advance digital innovation excite you? Do you love building and developing high performing teams? If you are passionate and want to be a part of Amgen’s mission to serve patients – every patient. Every time – then check out this exciting new opportunity.

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen's manufacturing plant at Puerto Rico. The facility continues to implement new technologies and industry 4.0 capabilities. On this role you may also support projects at other Amgen facilities.

• Lead the execution and successful delivery of varied portfolio of IS/Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by utilizing technical, project management, and business expertise.
• Performs cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Manage multiple initiatives and priorities.
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
• Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors.
• Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
• Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Principal Manufacturing Systems Engineer professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications:

Doctorate degree in Engineering and 2 years of combined Information Systems and Manufacturing Process Automation experience

Or

Master’s degree in Engineering and 4 years of combined Information Systems and Manufacturing Process Automation experience

Or

Bachelor’s degree in Engineering and 6 years of combined Information Systems and Manufacturing Process Automation experience

Preferred Qualifications:

• Engineering, Information Systems, Computer and/or Software GMP-regulated industry background with experience leading projects and resources.
• 8+ years of experience in manufacturing, including 5+ in Pharma/Biotech industry.
• 5+ years of combined experience with Automation/ Process Control Systems (PCS), Manufacturing Execution System (MES) and/or laboratory systems or IS platforms.
• 5+ years of experience with packaging and/or filling line systems.
• Proficient in two or more of the following software: Rockwell FactoryTalk, Rockwell PLCs, and/or OSIsoft PI Data Historian.
• Experience with Korber MES.
• Strong knowledge of GAMP software development lifecycle, ANSI/ISA-S88 & S95 industry standards and methodologies.
• Experience or knowledge of advanced technologies around Augmented Reality/Virtual Reality, Location tracking, Digital Control tower, Industrial Internet of Things (IIoT), and Instrument Data Acquisition (IDA).
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11.
• Validation and change control methodology experience with understanding of cyber security and manufacturing network principles as applied to operations technologies.
• Experience in PCS/MES implementation, validation, and change control.
• Strong communication, leadership, and teamwork skills.
• Innovative, technically minded, and problem-solving abilities.
• Effective verbal, and written communication, and facilitation skills in the English language.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.