Associate Manufacturing Job at Amgen (Thousand Oaks)

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

The Associate of Manufacturing will work in a dynamic production environment at ...

Location

United States , Thousand Oaks

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 2 years of manufacturing or operations work experience
Associate degree and 6 months of manufacturing or operations work experience
Bachelor's degree

Job Responsibility

Perform and monitor critical manufacturing processes
Execute routine validation protocols
Comply with GMP requirements and all safety and compliance expectations
Draft and revise routine documents such as MPs, SOPs, and technical reports
Initiate and own quality records, including CAPA and CAPA-EV
Identify and recommend improvements to routine functions and implement approved changes
Perform basic troubleshooting and accurately recognize and report problems
Direct operators on critical processes
Assist in the review of documentation for assigned functions, including routine area audits and batch records
Perform activities that may include rigorous and repetitive work

What we offer

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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Associate Manufacturing

Let’s do this! Let’s change the world! The Associate of Manufacturing will work ...

Location

United States , Thousand Oaks

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 2 years of manufacturing or operations work experience
or Associate degree and 6 months of manufacturing or operations work experience
or Bachelor’s degree

Job Responsibility

Perform and monitor critical manufacturing processes
Execute routine validation protocols
Comply with GMP requirements and all safety and compliance expectations
Draft and revise routine documents such as MPs, SOPs, and technical reports
Initiate and own quality records, including CAPA and CAPA-EV
Identify and recommend improvements to routine functions and implement approved changes
Perform basic troubleshooting and accurately recognize and report problems
Direct operators on critical processes
Assist in the review of documentation for assigned functions, including routine area audits and batch records
Perform activities that may include rigorous and repetitive work

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
Discretionary annual bonus program or sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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

New

Senior Associate Manufacturing I

In this role you will be managing and leading all aspects of a device assembly &...

Location

United States , New Albany

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
Or Master's

Job Responsibility

Managing and leading all aspects of a device assembly & packaging line
Maintaining production in full cGMP compliance
Assisting with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed
Leading manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting
Maintaining machine uptime, perform any fault clearing and clear stoppages on automated equipment
Ensuring all safety and compliance procedures are followed at all times
Raising appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk
Providing training to manufacturing staff on process and equipment
Providing troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor
Collaborating with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner

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

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