Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)

Amgen Inc. (IR); Holly Springs (NC); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Flexible work models

Job summary

Amgen Inc. is hiring a Senior Associate Manufacturing - Electronic Batch Record Support to help start up the NC facility. You will generate EBRs using PAS-X, troubleshoot in real time, and support MES integrations across multiple manufacturing areas.

You will contribute to Lean initiatives, create and improve SOPs, and participate in projects introducing new manufacturing technologies for patient-focused therapies.

Qualifications

• High School/GED with 4 years manufacturing experience
• Associate's Degree with 2 years manufacturing experience
• Bachelor's Degree with 6 months manufacturing experience
• Master's Degree

Responsibilities

• Generate Electronic Batch Records (EBR) using PAS-X and edit/ troubleshoot in real time.
• Support MES integrations and new functionalities for manufacturing.
• Create and maintain EBRs; optimize them to match process requirements.
• Contribute to Lean Transformation by tracking EBR metrics and applying improvement tools.
• Collaborate on projects introducing new products and manufacturing technologies.

Skills

Electronic batch records

PAS-X (Korber)

MES integrations

cGMP manufacturing

Education

Bachelor's Degree (related field)

Associate's Degree

High School/GED

Master's Degree

Tools

SAP

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)

What you will do Let’s do this! Let’s change the world! In this vital role, you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of EBR metrics and for communication between the operations teams and the various functional groups working through start-up activities. During start up, Manufacturing Senior Associates will have oversight of electronic batch records operational readiness activities in multiple manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, and Column Packing. Manufacturing Senior Associates can also support Standard Operating Procedure (SOP) creation, review, and approval; design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff.

Job scope and responsibilities

Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes. Assist in the implementation of new MES integrations and functionalities. Support manufacturing in the troubleshooting and execution of EBRs Create and maintain Electronic Batch Records Support optimization of EBRs to improve functionality and align with process requirements Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools. Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.

What we expect of you

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

Basic Qualifications

• High School/GED and 4 years of manufacturing or operations work experienceOR Associate’s Degree and 2 years of manufacturing or operations work experienceOR Bachelor’s Degree and 6 months of manufacturing or operations work experienceOR Master’s Degree

Preferred Qualifications

• Completion of NC BioWorks Certification Program.
• Experience in biotechnology or pharmaceutical plant start up.
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
• Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
• Excellent verbal and written communication (technical) skills.
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
• Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible.

Salary Range

86,048.05USD -116,417.95 USD

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