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

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing to support the start-up of its NC facility. You will generate electronic batch records, coordinate with operations and functions, and help implement MES enhancements during early operations.

The role requires strong communication, familiarity with PAS-X, SAP/MES, and cGMP manufacturing processes, with opportunities to contribute to continuous improvement and manufacturing excellence.

Qualifications

• High School/GED with 4 years of manufacturing or operations experience, OR an Associate’s Degree with 2 years.
• Bachelor’s Degree with 6 months of manufacturing or operations experience, OR Master’s Degree.
• NC BioWorks Certification Program is preferred; biotech/pharma start-up experience is desirable.

Responsibilities

• Generate and manage Electronic Batch Records (EBR) using PAS-X (Korber); edit and validate records.
• Assist in implementing new MES integrations and functionalities.
• Troubleshoot EBRs and support operations in multiple manufacturing areas.
• Create and maintain Electronic Batch Records; optimize EBRs for better functionality.
• Contribute to Lean initiatives by tracking EBR metrics and supporting continuous improvement.

Skills

Communication skills

Microsoft Office

Upstream/Downstream knowledge

Biotech/pharma start-up experience

cGMP manufacturing knowledge

Education

Bachelor’s Degree

Master’s Degree

Associate’s Degree

High School/GED

NC BioWorks Certification Program

Tools

SAP

EBS/MES

DeltaV

Electronic Quality Systems

PAS-X (Korber)

Job description

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.

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