Drug Product Manufacturing Associate I Job at PCI Pharma Services (San Diego)

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

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, 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

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 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
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
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
Flexible work models where possible

Fulltime

Production Associate - Fill

The Production Associate contributes to saving and sustaining lives by inspectin...

Location

United States , Marion

Salary:

17.88 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must be at least 18 years of age
Must have basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Must be able to perform basic mathematics
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
CRC (Career Readiness Certification) at the Silver level, preferred
Requires continuous grasping, pushing/pulling up to 12 pounds for up to 25 feet and reaching with hands and arms
Lifting on average up to 16 pounds to/from a height of up to 46 inches constantly throughout the shift
Carrying on average up to 10 pounds for 5 feet constantly throughout the shift

Job Responsibility

Over-pouch and seal the over-pouch, enclosing a bag containing solutions or premixed drugs, at a rate consistent with production needs
Inspect and ensure that the over-pouches, bags and their components meet quality standards
Perform scheduled quality checks using an assortment of gauges and a scale
Perform and document scheduled cleaning activities
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Sustain a clean and safe work area using 6S principles
Correct any over-pouch seal or packaging issues previously identified

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Fulltime

Production Associate, Fill

The Production Associate, Fill is an Hourly Non-Exempt position which contribute...

Location

United States , Marion

Salary:

18.40 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must have a High School Diploma or GED
Must be at least 18 years of age
CRC (Career Readiness Certification) at the Silver level, preferred
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
Basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Ability to perform basic mathematics
Requires continuous grasping, pushing/pulling up to 40 pounds for a distance up to 50 feet and reaching with hands and arms up to 18 inches
Lifting and carrying on average up to 12 pounds frequently throughout the shift

Job Responsibility

Fill, assemble and plug flexible containers with solutions or premixed drugs at a rate consistent with production needs
Print labeling and bar code information on the flexible containers using a computerized printer
Maintain the printer by replacing printer foil, ribbon and by making minor adjustments
Supply the filling stations with printed bags and other supplies necessary to assemble the flexible container
Inspect and ensure that the printed bags and their components meet quality standards
Perform and document scheduled cleaning activities
Perform scheduled quality checks using an assortment of gauges and a scale
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Sustain a clean and safe work area using 6S principles.

What we offer

Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Parttime

Senior Manufacturing Associate – Single Use Systems (SUS)

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

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED and 4 years of manufacturing or operations work experience
Associate’s Degree and 2 years of manufacturing or operations work experience
Bachelor’s Degree and 6 months of manufacturing or operations work experience
Master’s Degree
Experience with and understanding of Single-Use Systems
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

Job Responsibility

Support New Product introduction and projects through SUS mapping/drawing
Maintain and edit SUS Standard Operating Procedures (SOP)
Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings
Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation
Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects
Provide input for ANC representative to SUS network for improvements and troubleshooting
Support Vendor Change Notification assessments
Understand single-use material capabilities and user requirements for new technologies through interaction with end users
Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow

What we offer

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

Fulltime

Production Associate, Pouch Part-Time Weekend

The Production Associate, Pouch is an Hourly Non-Exempt position which contribut...

Location

United States , Marion

Salary:

18.40 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must have a high school diploma or GED
Must be at least 18 years of age
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
CRC (Career Readiness Certification) at the Silver level, preferred
Basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Ability to perform basic mathematics
Requires continuous grasping, pushing/pulling up to 12 pounds for up to 25 feet and reaching with hands and arms
Lifting on average up to 16 pounds to/from a height of up to 46 inches constantly throughout the shift

Job Responsibility

Over-pouch and seal the over-pouch, enclosing a bag containing solutions or premixed drugs, at a rate consistent with production needs
Inspect and ensure that the over-pouches, bags and their components meet quality standards
Perform scheduled quality checks using an assortment of gauges and a scale
Perform and document scheduled cleaning activities
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Sustain a clean and safe work area using 6S principles
Correct any over-pouch seal or packaging issues previously identified

What we offer

Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Flexible Spending Accounts
Educational assistance programs
Employee Assistance Program (EAP)

Parttime

Manager Manufacturing, New Product Introduction

In this vital role you will act as the Manager for the New Product Introduction ...

Location

United States , Holly Springs

Salary:

126376.00 - 159170.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Manufacturing or Operations experience
Associate’s degree and 10 years of Manufacturing or Operations experience
Bachelor’s degree and 5 years of Manufacturing or Operations experience
Master’s degree and 3 years of Manufacturing or Operations experience
Doctorate degree

Job Responsibility

Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant
Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs
Lead team meetings and drive alignment in business processes across the team
Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements and/or advanced technologies into the plant
Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level
Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings
Drive a culture of inspection readiness across the team
Interacts with management in planning, developing, and maintaining budget
Assist in developing and maintaining department goals
Interact with regulatory agencies as needed

What we offer

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

Fulltime

Production Associate, Fill Part-Time Weekend

The Production Associate, Fill is responsible for inspecting, printing, filling,...

Location

United States , Marion

Salary:

18.40 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must have a High School Diploma or GED
Must be at least 18 years of age
CRC (Career Readiness Certification) at the Silver level, preferred
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
Basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Ability to perform basic mathematics
Requires continuous grasping, pushing/pulling up to 40 pounds for a distance up to 50 feet and reaching with hands and arms up to 18 inches
Lifting and carrying on average up to 12 pounds frequently throughout the shift

Job Responsibility

Fill, assemble and plug flexible containers with solutions or premixed drugs at a rate consistent with production needs
Print labeling and bar code information on the flexible containers using a computerized printer
Maintain the printer by replacing printer foil, ribbon and by making minor adjustments
Supply the filling stations with printed bags and other supplies necessary to assemble the flexible container
Inspect and ensure that the printed bags and their components meet quality standards
Perform and document scheduled cleaning activities
Perform scheduled quality checks using an assortment of gauges and a scale
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Sustain a clean and safe work area using 6S principles.

What we offer

Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Flexible Spending Accounts
Educational assistance programs
Paid holidays and paid parental leave

Parttime

Drug Product Manufacturing Associate I

PCI Pharma Services

Location:
United States , San Diego

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 20, 2026

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