CrawlJobs Logo
PCI Pharma Services Logo PCI Pharma Services · Manufacturing

Drug Product Manufacturing Associate I

United States, San Diego 21.98 - 25.64 USD / Hour · Job Posted February 20, 2026
Apply Position
Job Link Share

Job Description

The Manufacturing Associate I is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

Job Responsibility

  • Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility
  • Train on required SOP's and execute training curriculum
  • Prepare materials needed for aseptic operations
  • Performs various routine manufacturing tasks on complex equipment under the guidelines of established SOP’s and cGMP regulations
  • Accurately documents data and completes batch records as needed
  • Reliably executes well defined SOP’s
  • Operates in clean room environments in accordance with established policies and procedures
  • Collects and disposes of lab wastes according to established procedures
  • Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
  • Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture

Requirements

  • High school diploma required
  • Bachelors in a science or engineering discipline preferred
  • Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions
  • Ability to follow instructions with direct supervision
  • Detail oriented with strong written and verbal communication skills
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment
  • Familiarity with cGMP, manufacturing, machine operations, and data entry
  • Must be familiar with Microsoft Office applications

What we offer

  • Paid time off
  • Health insurance coverage (including dental and vision)
  • Flexible spending account
  • 401(k) plan
  • Eligibility for an annual performance bonus
PCI Pharma Services - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Drug Product Manufacturing Associate I

8 matching positions

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...
Location
Location
United States , Thousand Oaks
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...
Location
Location
United States , Thousand Oaks
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Manufacturing Associate – Single Use Systems (SUS)

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Manager Manufacturing, New Product Introduction

In this vital role you will act as the Manager for the New Product Introduction ...
Location
Location
United States , Holly Springs
Salary
Salary:
126376.00 - 159170.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Manager Manufacturing

The Manager Manufacturing – Drug Product Inspection role offers the opportunity ...
Location
Location
United States , Thousand Oaks
Salary
Salary:
106148.00 - 143612.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree OR Master's degree and 3 years of drug product manufacturing or operations experience OR Bachelor's degree and 5 years of drug product manufacturing or operations experience OR Associate's degree and 10 years of drug product manufacturing or operations experience OR High school diploma / GED and 12 years of drug product manufacturing or operations experience
  • In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Job Responsibility
Job Responsibility
  • Staff selection, training, oversight, performance, and development
  • Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities
  • Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor
  • Elevating critical and impactful events to senior management and making real time processing decisions
  • Ensuring standard operating procedures are accurate for performing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation
  • Using appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
  • Identifying and implementing process and safety improvements
  • Communicating production floor and project work at different levels of management
  • Interacting with business partners and internal/external audit teams including regulatory agencies as required
  • Working with business partners to assist with the scheduling of maintenance tasks, engineering evaluations, and quality investigations
What we offer
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
Read More
Arrow Right

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED & 10 years of biotechnology operations experience
  • Associate’s degree & 8 years of biotechnology operations experience
  • Bachelor’s degree and 4 years of biotechnology operations experience
  • Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
  • Doctorate degree
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in Downstream GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
  • Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Job Responsibility
Job Responsibility
  • Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
  • Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
  • Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
  • New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
  • Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
  • Support Manufacturing in troubleshooting, problem solving and RCAs
  • Support CAPA development to prevent error recurrence
  • Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
  • Responds to regulatory questions and/or audit findings
  • Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Senior Associate, Manufacturing

The Senior Associate reports to the Manager Manufacturing. The ideal candidate w...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Engineer - Internal Process Engineering

Let’s do this. Let’s change the world. In this vital role you will join Amgen’s ...
Location
Location
United States , Thousand Oaks; Cambridge
Salary
Salary:
115494.60 - 156257.40 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • Or Master's degree and 2 years of Operations or Process Development experience
  • Or Bachelor's degree and 4 years of Operations or Process Development experience
  • Or Associate's degree and 8 years of Operations or Process Development experience
  • Or High school diploma / GED and 10 years of Operations or Process Development experience
Job Responsibility
Job Responsibility
  • Lead or support commercial technology transfers by executing make-a-batch assessments to determine facility fit, designing and executing offline and on-site characterization studies, authoring high-quality process transfer documentation, providing on-site support, and evaluating potential product impacts due to process, scale, equipment, and raw material changes
  • Work collaboratively with a team of process scientists and engineers to design, implement, and document process development and technology transfer activities, generating primary data packages while applying expertise in aseptic processing, equipment, automation, and unit operation characterization
  • Serve as a drug product technical specialist providing solutions for parenteral manufacturing across unit operations including, but not limited to, formulation, sterile filtration, filling, capping, lyophilization, and visual inspection
  • Support continuous improvement in drug product development and manufacturing through application of first principles in process engineering and by leveraging data-driven approaches, including advanced data analytics, modeling, and emerging AI-enabled tools to enhance process understanding and robustness
  • Support technology transfers for pipeline and commercial products and contribute to lifecycle management activities across a range of parenteral modalities
  • Deliver clear progress reports and technical presentations to management and project teams to communicate status, risks, and key findings, and escalate issues or unresolved technical challenges through appropriate governance channels
  • Participate in global cross-functional teams, working effectively within a highly matrixed environment to advance programs through clinical manufacturing and commercialization
  • Build and sustain strong relationships with drug product development teams and manufacturing partners to ensure alignment between program needs, process requirements, and site capabilities
  • Apply fundamental scientific (biochemistry, biophysics, statistics) and engineering principles (equipment, automation, chemical, mechanical) to support process characterization, scale-up, and troubleshooting activities
  • Explore and implement opportunities to utilize digital and AI-enabled approaches for process
What we offer
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
Read More
Arrow Right