Sr Associate Digital Manufacturing (12hr PM)

Amgen Inc. (IR); New Albany (OH); On-site; USD 94,000 - 127,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Discretionary bonus

Stock incentives

Flexible work models

Job summary

Amgen Ohio is seeking a Sr Associate Digital Manufacturing to lead smart manufacturing technology initiatives on the shop floor, including AR/VR, MES, ERP, SCADA, and Systech. You will design, implement and validate key digital systems, develop master batch records, and ensure GMP compliance.

The role requires collaboration across functions, strong problem solving, and ability to deliver on time while driving continuous improvement. Amgen offers competitive benefits and a path for career growth.

Qualifications

• High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.
• Or Associate’s Degree and 2 years of Manufacturing, Engineering or Computer Science experience.
• Or Bachelor’s Degree and 6 months of Manufacturing, Engineering or Computer Science experience.
• Or Master’s Degree.

Responsibilities

• Provides technical support, project management, and problem solving assistance of various smart manufacturing technology and computerized systems within the manufacturing area.
• Department lead of smart manufacturing technology, computerized systems, and Manufacturing Execution System (MES) and represent site on global network initiatives.
• Support Amgen Ohio digital manufacturing team to trouble shoot and develop new ways of working.
• Act as manufacturing business representative in multi‑functional meetings and support all levels of the organization to drive digital manufacturing projects.
• First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, MES and ERP.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
• Support key business system lifecycle management and represent team during system upgrades, improvement and maintenance projects.
• Generate, and review documents (SOPs, FORMs, FMEAs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
• Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end‑users.(Operators/Supervisors/Technical/QA/Support Staff).
• Actively assist during trouble shoot and apply problem solving skills.
• Uses the latest data analytics tools and methodologies to tackle systematic problems and improve process efficiencies to maintain production schedule alignment.

Skills

Manufacturing experience

Engineering experience

Computer science knowledge

Problem solving

Team collaboration

Education

High School/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

MES

ERP

SCADA

Systech

Serialization

Job description

Career Category Operations 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. 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.

Sr Associate Digital Manufacturing

What you will do Let’s do this. Let’s change the world. In this role you will lead various smart manufacturing technology and computerized systems initiatives within manufacturing to support the end user on the shop floor (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization). You will manage critical processes, provide technical leadership, and be accountable for designing, implementation, and validation of key business systems and digital technologies. You will support the development of master batch records, technical reports, and other Good Manufacturing Practices (GMP) documents that supports smart manufacturing technology and the production process. This role is essential for Amgen Ohio’s success and key in supporting operations towards the digital future of tomorrow.

Responsibilities

• Provides technical support, project management, and problem solving assistance of various smart manufacturing technology and computerized systems within the manufacturing area.
• Department lead of smart manufacturing technology, computerized systems, and Manufacturing Execution System (MES) and represent site on global network initiatives.
• Support Amgen Ohio digital manufacturing team to trouble shoot and develop new ways of working.
• Act as manufacturing business representative in multi‑functional meetings and support all levels of the organization to drive digital manufacturing projects.
• First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, MES and ERP.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
• Support key business system lifecycle management and represent team during system upgrades, improvement and maintenance projects.
• Generate, and review documents (SOPs, FORMs, FMEAs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
• Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end‑users.(Operators/Supervisors/Technical/QA/Support Staff).
• Actively assist during trouble shoot and apply problem solving skills.
• Uses the latest data analytics tools and methodologies to tackle systematic problems and improve process efficiencies to maintain production schedule alignment.
• Ensure all actions and responsibilities are completed on time and current schedule is maintained, accurate, and up to date, including proactive communication regarding scheduling challenges and provide possible solutions.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

• High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.
• Or Associate’s Degree and 2 years of Manufacturing, Engineering or Computer Science experience.
• Or Bachelor’s Degree and 6 months of Manufacturing, Engineering or Computer Science experience.
• Or Master’s Degree

Preferred Qualifications

• Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
• Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user on the shop floor (e.g. MES, ERP, SCADA, Systech, Serialization).
• Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to a System requirements for the end user (ERP and MES).
• Experience in deviations, investigations, root cause analysis, CAPA’s and change controls.
• Analytical fact‑based problem solver and strong trouble shooting skills on process, equipment, smart technology, and computerized systems.
• Ability to maintain an environment of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
• The ability/experience working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able adapt quickly to the demands of commercial manufacturing operations.
• Pro‑active, result oriented, and ability to prioritize work to meet timelines.
• Good documentation practices and skills including technical writing
• Good communication to all levels of the organization.

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 and vision coverage, life and disability insurance, and flexible spending accounts
• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application & Offer Policies

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity / EEO Statement

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.

Salary Range

93,542.50USD -126,557.50 USD

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen