Associate Manufacturing - Days Job at Amgen (West Greenwich)

Associate Manufacturing – Downstream - Days

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

Location

United States , Holly Springs

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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

Job Responsibility

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
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) 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 (Electronic Batch Records [EBRs])
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 (i.e., equipment logs, EBRs)

What we offer

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

Fulltime

Senior Associate Manufacturing, Upstream - Days

Join Amgen’s Mission of Serving Patients. Be part of Amgen's newest and most adv...

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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

Job Responsibility

Execute on-the-floor operations within manufacturing in accordance with cGMP practices
Work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime
Complete 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
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

What we offer

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

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

Manufacturing Associate - Day Shift

Join our dynamic team at the Windsor Production facility, where we’re looking to...

Location

United States , Windsor

Salary:

23.50 - 28.00 USD / Hour

vestas

Expiration Date

October 31, 2026

Requirements

High school diploma or general education degree (GED) required
Two years of experience of either Manufacturing, Trade Labor, Craning, or Fabrication experience is required
Must be able to communicate effectively in English, including reading, writing, and speaking
Ability to read and comprehend instructions, short correspondence, and memos
Must pass confined spaces test as required
Must be able to pass a respiratory fit test as required

Job Responsibility

Efficiently operates manufacturing equipment with a strong commitment to safety protocols
Adheres to Process Work Instructions and engages in manual production processing to accurately fit and assemble components, such as bolts, screws, shafts, or bearings into a complete assembly
Exceed our production benchmarks by completing specific tasks within the designated timeframe, playing a key role in the collective success of our team objectives
Lift, position, and/or remove material from work areas
Load, stack and transport materials by hand, truck, crane or jib
Read and comprehend Work Process Instructions and translate that into the ability to perform the tasks
As well as any ad hoc duties that may be assigned

What we offer

Benefits coverage within your first month
State-of-the-art Training Program
Paid Time Off (PTO)
Excellent 401(k) plan
Annual bonus

Fulltime

Senior Associate, Manufacturing

The Senior Associate reports to the Manager Manufacturing. The ideal candidate w...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Educated to pass Leaving Certificate standard or equivalent
Applicants should have relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment
Significant experience in a GMP/other regulated environment
Demonstrated knowledge of GMP principles
Demonstrated aseptic knowledge in GMP areas
Drug product manufacturing experience
Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels
Demonstrated ability to deliver to team, site and personal objectives
Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts
Results-oriented

Job Responsibility

Responsible for leading the shift in conjunction with FLM
Responsible for outlining roles for the day, ensuring schedule is on track, triaging events, writing deviations, Batch Record Review, Running MDI’s
Oversees opportunities from project from training perspective in project phase
Support development of SOPs/job-aids/guidance
Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards
Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule
Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans
Maintain an accurate, up-to-date manufacturing schedule reflecting current status of production and plan critical path activities
Foster a good safety culture in our team and act as a safety role model
Oversee completion and review of documentation (batch records, EBRs) using relevant software systems and Standard Operating Procedures (SOPs)

What we offer

Health and welfare plans for staff and eligible dependents
Retirement and savings plan with generous company contributions
Group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development, and career advancement opportunities

Fulltime

Manufacturing Validation Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software
Some experience with statistical software helpful

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Manufacturing Validation Associate II

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful
Direct or indirect industry knowledge

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Associate IS Analyst – Manufacturing Systems

In this role on the Amgen Manufacturing Systems team, you will install, upgrade,...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s or bachelor’s degree and 2 -5 year of Information Systems experience or related field
2–5 years of experience in Information Systems, Manufacturing Systems, Automation, or related roles in a regulated industry
Experience supporting or implementing MES, PI, or other manufacturing/automation systems in pharmaceutical, biotechnology, or industrial environments
Experience in GxP-regulated environments, including system validation, change control, and documentation
Good understanding of SDLC, requirements, design, testing, data analysis, and production support
Hands-on exposure to one or more manufacturing platforms such as PAS|X MES, GE Proficy, AVEVA PI, SCADA, OEE, or related systems
Experience with system integration across SAP, MES, PI, and Level 2 automation systems such as PLCs, SCADA, DCS, or OPC
Strong skills in troubleshooting, technical documentation, stakeholder engagement, and cross-functional collaboration

Job Responsibility

Support day-to-day operations, maintenance, and continuous improvement of Amgen’s manufacturing systems, including MES, PI, SCADA, OEE, RTMSPM, scheduling applications, and related site systems
Collaborate with business and data stakeholders to gather requirements, assess data needs, and ensure data integrity and compliance
Analyze functional and technical requirements and translate them into solution design and configuration specifications
Support design, configuration, implementation, and validation of manufacturing systems, with emphasis on MES and PI platforms
Contribute to project phases including design, build, test, deployment, hypercare, and operational support
Troubleshoot technical issues, support incident response, and perform root cause analysis to minimize downtime
Develop and execute unit tests, integration tests, and validation activities in alignment with IS change control and GxP validation processes
Support integrations with SAP, automation systems, and other enterprise or plant platforms to enable seamless data flow and functionality
Create and maintain technical and functional documentation, validation protocols, SOPs, and training materials
Monitor system performance, support patching and upgrades, and ensure platform stability and compliance

Fulltime

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Associate Manufacturing - Days

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