Senior Associate Manufacturing - Holly Springs, NC

VetJobs

Holly Springs (NC)

On-site

USD 86,000 - 116,000

Full time

34 hours ago

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Job summary

Amgen in Holly Springs, NC seeks a Senior Associate to support facility expansion, startup and 24/7 manufacturing operations. You will participate in equipment prep, qualification and process walkthroughs, ensuring readiness and continuous improvement across QA/QC, F&E, PPIC, and Regulatory teams.

The role requires diverse experience in manufacturing, cGMP compliance, and hands-on process execution, with potential shifts and overtime during startup and commissioning phases.

Qualifications

High School Diploma/GED plus 4 years in manufacturing or regulated environment.
Associate’s/Bachelor’s/Master’s degree with related experience.
Biotech/pharma plant startup experience preferred.

Responsibilities

Support operational readiness activities for facility expansion and startup.
Execute manufacturing readiness tasks including equipment prep and process walkthroughs.
Participate in commissioning, qualification, and startup activities.
Provide operational feedback to support safe, compliant manufacturing.
Support readiness planning through procedures, workflows and training.

Skills

Manufacturing operations

cGMP knowledge

Quality systems

Cross-functional collaboration

Documentation SOPs

Education

High School diploma/GED

Associate degree

Bachelor’s degree

Master’s degree

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Let’s do this! Let’s change the world! In this dynamic role, you will be an Senior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and ramp‑up of manufacturing operations within the new facility.

This role may require work outside standard business hours, including non‑standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of the startup, you will be expected toworkaMonday – Friday schedule from 8am – 5pm. As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.

During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.

Compliance

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance

Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed

Operational Readiness & Facility Startup

Support operational readiness activities for facility expansion and startup
Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs
Participate in commissioning, qualification, and startup activities as trained and assigned
Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing
Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp‑up

Process/Equipment/Facilities

Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)
Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Responsible for recognizing and elevating problems during daily operations
Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
Drive safety in all operations, and assist the manager in escalating concerns as needed
Maintain an organized, clean, and workable space

Administrative

Draft and revise documents (SOPs, technical reports, and MPs)
Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

What we expect of you

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

Basic Qualifications

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR
Master's Degree

Preferred Qualifications

Completion of NC BioWork Certificate Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

86,048.05USD -116,417.95 USD

City*

Holly Springs

State*

North Carolina

Job_Category

Manufacturing

Job Code

Pharmaceutical Pharmaceutical

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