Associate Manufacturing – Downstream - Days Job at Amgen (Holly Springs)

Associate Manufacturing - Bulk Drug Substance Downstream - Days

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or Bachelor's Degree
Completion of NCBioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Job Responsibility

Completes work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions
Perform documentation for assigned functions

What we offer

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

Fulltime

Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

Amgen is seeking a Manager Manufacturing Downstream to provide frontline leaders...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Lead, develop, and coach a manufacturing team
set clear performance expectations
foster a strong culture of safety, quality, and accountability
Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility
Ensure safe, cGMP-compliant execution
drive performance across safety, quality, schedule, and cost
resolve deviations and operational issues
Support transfer and implementation of manufacturing processes
ensure manufacturability, troubleshooting, and continuous improvement
Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp-up

What we offer

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

Fulltime

Senior Associate Manufacturing

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years manufacturing and operations experience OR Associate's + 2 years manufacturing and operations experience OR Bachelor's + 6 months manufacturing and operations experience Master's
Degree in Engineering or Life Sciences
3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical area
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
Ability to drive results through leadership of cross-functional teams
Experience leading and managing projects
Understanding of single-use technologies

Job Responsibility

Support manufacturing by providing subject-matter expertise for drug substance downstream processes as Single-use SME
Resolve quick issues and implement function tests to troubleshoot and optimize process
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
Own Quality Records, such as CCMS, CAPA, and CAPA-EV
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
Demonstrate strategic problem-solving skills and champion continual improvement
Ability to be on-site (flexible worker)
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills

What we offer

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

Fulltime

Front Line Manufacturing Manager (Downstream) - Day Shift

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

111714.00 - 139899.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensure safe working environment
Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
Evaluate current operating procedures and recommend changes to management to optimize production
Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes
Interact with regulatory agencies as needed
Assure proper gowning and aseptic techniques are followed
Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
Recruit, train, evaluate, coach and develop staff
Mentor and coach staff members to live by the Amgen Values
Develop and implement trainings plans and programs, to ensure staff are prepared and compliant

What we offer

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

Fulltime

Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift

Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift ...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master's degree and 3 years of Manufacturing or Operations experience
Bachelor's degree and 5 years of Manufacturing or Operations experience
Associate's degree and 10 years of Manufacturing or Operations experience
High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensure safe working environment
Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
Evaluate current operating procedures and recommend changes to management to optimize production
Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes
Interact with regulatory agencies as needed
Assure proper gowning and aseptic techniques are followed
Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
Recruit, train, evaluate, coach and develop staff
Mentor and coach staff members to live by the Amgen Values
Develop and implement trainings plans and programs, to ensure staff are prepared and compliant

What we offer

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

Fulltime

New

Senior Process Engineer - Solution Prep, Upstream, and Downstream

In this vital role you will be joining the Facilities & Engineering (F&E) group ...

Location

United States , Holly Springs

Salary:

115494.60 - 156257.40 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Engineering experience
OR Bachelor's degree and 4 years of Engineering experience
OR Associate's degree and 8 years of Engineering experience
OR High school diploma / GED and 10 years of Engineering experience

Job Responsibility

Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams
Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items
Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements
Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed
Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required
Responsible system owner for Solution Prep, Upstream, and Downstream Drug substance process equipment, areas, and systems providing end-to-end support for operations
Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations
Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable
Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment
Develop master maintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order

Fulltime

Order Support Manager

The Order Support Manager leads a team of approximately 10–12 Order Entry Specia...

Location

United States , Greenwood; Houston; Richmond; Warminster

Salary:

80000.00 - 115000.00 USD / Year

Alfa Laval

Expiration Date

Until further notice

Requirements

Associates or Bachelor's degree in Business Administration, Operations Management, Supply Chain, or a related field preferred. Equivalent combination of education and relevant work experience will be considered.
3+ years of experience in order entry, order management, inside sales support, or supply chain coordination within an industrial equipment, manufacturing, or capital goods environment.
2+ years of people leadership experience, including team supervision, performance management, and individual coaching.
Experience managing high-volume, accuracy-sensitive transaction processing teams is strongly preferred.
Deep understanding of the purchase order validation and order entry process, including the downstream impact of data errors on fulfillment, customer communication, and revenue recognition.
Demonstrated ability to manage team performance through data — comfortable owning accuracy and throughput KPIs, identifying error patterns, and implementing corrective action.
Proficiency with ERP and order management platforms (experience with SAP, OneService, or similar enterprise systems preferred).
Detail-oriented and process-disciplined — able to build and enforce a quality-first culture without creating a punitive environment.
Strong communicator across functions — able to work constructively with peer managers (Quote Support, Customer Fulfillment, Workflow Optimization) to resolve shared operational challenges.
Comfortable leading a team through change — able to translate new processes and tool updates into clear, practical direction for frontline team members.

Job Responsibility

Leads, coaches, and develops a team of approximately 10–12 Tier 1 Order Entry Specialists
Conducts regular 1:1s, team huddles, and performance reviews
Partners with the Training & Knowledge Specialist to identify skill gaps and build targeted development plans
Manages day-to-day team scheduling, workload distribution, and capacity planning
Responsible for the recruitment, onboarding, and ramp-up of new Quote specialists
Oversee the daily order entry operation to ensure team delivers against SLAs
Reviews and resolves escalated order entry issues
Monitors quote accuracy rate (target: 98% error-free) and takes corrective action
Monitors the order entry accuracy rate (target: 98% error-free) and drives root cause review
Enforces data entry standards across all systems

What we offer

medical/dental/vision/life insurance
401(k) plan

Fulltime

Senior Manager Manufacturing Systems Engineering

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Holly Springs

Salary:

148715.15 - 201202.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering
Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus
Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing
Direct knowledge of integrating various OEM automation software and field instrumentation technologies
In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience with Tech Transfer, Process Design, and Commissioning & Qualification

Job Responsibility

Oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs
Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function
Support design reviews while partnering closely with the corporate engineering team
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS)
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls
Provide mentoring to develop and accelerate site technical automation capabilities

What we offer

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

Fulltime

Select Country

Associate Manufacturing – Downstream - Days

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?