Associate Manufacturing Job at Amgen (Holly Springs)

Associate Manufacturing

The Manufacturing Associate position is part of the Amgen, Thousand Oaks, Drug P...

Location

United States , Thousand Oaks

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support work experience
Associate's + 6 months biotech/pharma manufacturing/laboratory or manufacturing support work experience
Bachelor's

Job Responsibility

Performing 100% manual inspection
Post inspection packaging operation
Characterization and equipment management
Process improvement projects/assignments within operations
Quality systems (LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support clinical and commercial production
Maintain open communication between operations teams
Perform 100% manual inspection
Perform post manual inspection packaging operations

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program or sales-based incentive plan
Stock-based long-term incentives

Fulltime

Associate Manufacturing

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
Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
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 (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 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 (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
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)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities

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

Associate Manufacturing

Join Amgen’s Mission of Serving Patients. In this dynamic role you will collabor...

Location

United States , Thousand Oaks

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 2 years of Manufacturing experience
Associate’s degree and 6 months of Manufacturing experience
Bachelor’s degree
B.S. in a life science or related field (preferred)
2 years of work experience in a GMP environment (preferred)
Ability to perform computer operations, such as ability to navigate in MS Office and Excel
Ability to operate specialized equipment and computers as appropriate to the individual area
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)

Job Responsibility

Completing drug product filling activities
Performing initial review of manufacturing batch records
Maintaining a safe and compliant culture by identifying preventative measures
Creating and/or revising standard operating procedures
Leading continuous improvement initiatives, which may be cross-functional in nature
Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
Developing finite schedule for tasks including, but not limited to unit operations
Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
Elevating critical and impactful events to management
Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)

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
Stock-based long-term incentives
Award-winning time-off plans.

Fulltime

Associate manufacturing

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
Completion of NC BioWork Certificate Program (Preferred)
Experience in a regulated industry such as biotechnology or pharmaceutical (Preferred)
Basic understanding and process experience in a cGMP manufacturing facility (Preferred)
Excellent verbal and written communication (Preferred)
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems (Preferred)
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes (Preferred)

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 operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area
Run and monitor critical process tasks per assigned procedures
Buffer and Media preparation and transfer
Weigh and dispense of materials to be used in the preparation of Buffers and Medias
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
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions

What we offer

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

Fulltime

Associate Manufacturing

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

Location

United States , Thousand Oaks

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 2 years of Manufacturing experience
Associate’s degree and 6 months of Manufacturing experience
Bachelor’s degree
B.S. in a life science or related field (preferred)
2 years of work experience in a GMP environment (preferred)
Ability to perform computer operations, such as ability to navigate in MS Office and Excel
Ability to operate specialized equipment and computers as appropriate to the individual area
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)

Job Responsibility

Completing drug product filling activities, respectively
Performing initial review of manufacturing batch records
Maintaining a safe and compliant culture by identifying preventative measures
Creating and/or revising standard operating procedures
Leading continuous improvement initiatives, which may be cross-functional in nature
Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
Developing finite schedule for tasks including, but not limited to unit operations
Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
Elevating critical and impactful events to management
Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)

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.

Fulltime

Associate Manufacturing – Downstream - Nights

Associate in the manufacturing organization at Amgen North Carolina (ANC), suppo...

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

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 (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
Perform documentation for assigned functions (i.e., equipment logs, EBRs)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities

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, Drug Product

At Amgen, our mission—to serve patients—drives everything we do. As a Sr Associa...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 6 months of Manufacturing support experience OR Associate's degree and 2 years of Manufacturing support experience OR High school diploma / GED and 4 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen's electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

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
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Manufacturing Associate

Proven to Perform. From the edges of space to the bottoms of ocean, our material...

Location

United States , Monroe

Salary:

Not provided

ATI

Expiration Date

Until further notice

Requirements

At least one (1) year of manufacturing experience
High School diploma or GED
Basic computer skills
Basic math skills
Analytical and problem-solving skills

Job Responsibility

Operating the furnaces, cut-off saw, grinder, Glama, forklift, and crane
Setting up and operating machines safely within standard operating procedures
Detecting faulty equipment and defective material
Marking dimensions and using correct measuring tools such as tape measures
Adherence to all safety policies, practices, and procedures
Working from mill orders and procedures to obtain specifications
Maintaining all required work and material identification
Verifying data collection to maintain logs, records and other paperwork

Fulltime

Select Country

Associate Manufacturing

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Associate Manufacturing

Associate Manufacturing

Associate Manufacturing

Associate Manufacturing

Associate manufacturing

Associate Manufacturing

Associate Manufacturing – Downstream - Nights

Senior Associate Manufacturing, Drug Product

Manufacturing Associate

Our AI answers in your language