Sr Associate Manufacturing I

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this. Lets change the 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). Will manage critical processes provide technical leadership and be accountable for designing implementation and validation of these systems and digital technologies. Responsible for regularly drafting and revision 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 Ohios success and key in supporting operations towards the digital future of tomorrow.

Responsibilities may include but are not limited to:

• 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 networks and initiatives.
• Support the site in the project approvals prioritization and manage the roll-out and implementation of smart manufacturing technology concept initiatives for the manufacturing area.
• 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 and MES.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design improvements system configuration validation and investigations.
• Support digital manufacturing lifecycle management and represent team during software or system upgrades.
• Generate and review documents (SOPs FORMs 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).
• Trouble shoot and assist during problem solving.
• Uses the latest data analysis tools and methodologies to solve 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 errors or issues 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

Associates Degree and 2 years of Manufacturing Engineering or Computer Science experience.

Or

Bachelors Degree and 6 months of Manufacturing Engineering or Computer Science experience.

Or

Masters Degree within Manufacturing Engineering or Computer Science experience.

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 an Electronic Batch Record. (PAS X Werum Software)
• Experience in deviations investigations root cause analysis CAPAs 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 well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

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 including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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.

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