Biopharmaceutical Process Engineer

6 days ago

Thousand Oaks, California, United States Aditi Consulting Full time
Job Summary:

The Facilities and Engineering group within Manufacturing and Clinical Supply organization at Aditi Consulting is seeking a skilled Biopharmaceutical Process Engineer to join their team.

This role will report to the Senior Manager of Engineering and will be responsible for providing system ownership for Biopharmaceutical process equipment, identifying and implementing engineering-based improvements or upgrades, and directing and coordinating equipment maintenance.



Key Responsibilities:

Provide system ownership for Biopharmaceutical process equipment, ensuring they operate at peak capacity and are properly commissioned and qualified.
Identify and implement engineering-based improvements or upgrades to equipment or facility systems, including developing business cases and translating requirements into process equipment/system design.
Direct and coordinate equipment maintenance, ensuring systems are working efficiently and effectively.
Monitor systems to identify performance risks and implement risk reduction strategies.
Solve issues to support and reduce production downtime, leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Requirements:

Bachelor's degree in chemical or mechanical engineering.
4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation.
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.).
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects.

What We Offer:

Competitive pay rate range.
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

  • Biopharmaceutical Process Development Director

    6 days ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    Job Title: Director Process DevelopmentJob Summary:Amgen is seeking a highly skilled Director Process Development to lead the development and advancement of a large and diverse portfolio of biologic therapeutic molecules from research to IND and enable GMP supply for early clinical trials. The ideal candidate will have a strong background in...

  • Process Development Engineer

    4 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Process Development EngineerWe are seeking a highly skilled Process Development Engineer to join our team at ACL Digital. As a Process Development Engineer, you will play a critical role in the development and implementation of new processes and technologies to support the production of high-quality biopharmaceuticals.Key Responsibilities:Transfer...

  • Director of Biologics Process Development

    2 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job Title: Director Process DevelopmentThis is a challenging and rewarding role that requires a strong background in biopharmaceutical process development. As a Director of Process Development, you will lead a team of scientists and engineers responsible for the development and implementation of biologics processes.Key Responsibilities:Lead a team of...

  • Bioprocess Engineer

    2 weeks ago

    Thousand Oaks, California, United States 20BLOC Full time

    Job Title: Bioprocess and Facility EngineerWe are seeking an experienced Bioprocess and Facility Engineer to join our team at 20bloc, Inc. This role is critical in ensuring the successful development and implementation of our biopharmaceutical processes and facilities.Key Responsibilities:Develop and implement comprehensive project plans to ensure timely and...

  • Maintenance Technician Senior

    2 months ago

    Thousand Oaks, California, United States BioPharma Consulting JAD Group Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Maintenance Technician to join our team at BioPharma Consulting JAD Group. As a key member of our Facilities & Engineering Department, you will be responsible for overseeing the maintenance and repair of equipment and systems used in the biopharmaceutical industry.Key...

  • Senior Reliability Engineer

    4 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Senior Reliability EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:We are seeking a highly skilled Senior Reliability Engineer to join our team at ACL Digital. As a key member of our manufacturing team, you will be responsible for ensuring the reliability and quality of our equipment and facilities.Key Responsibilities:Develop...

  • Senior Plant Engineer

    1 week ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    About the Role:As a Senior Plant Engineer at BioSpace, Inc., you will be responsible for designing and implementing cost-effective projects and technologies within GMP plant systems in the biopharmaceuticals manufacturing environment. Your focus will be on systems supporting cleanrooms and controlled environments in a commercially licensed biologics...

  • Reliability Engineer

    2 weeks ago

    Thousand Oaks, California, United States SSI People Full time

    Job Title: Senior Reliability Engineer- OnsiteLocation: Not SpecifiedPay Rate: $50/hr to $52/hrResponsibilities:Develop and implement engineering solutions to improve equipment and facility systems. This includes creating business cases, identifying design requirements, and translating requirements into process equipment/system design, specification, and...

  • Senior Reliability Engineer

    2 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Senior Reliability EngineerLocation: Thousand Oaks, CADuration: 12 MonthsJob Summary:We are seeking a highly skilled Senior Reliability Engineer to join our team at ACL Digital. As a key member of our engineering team, you will be responsible for ensuring the reliability and efficiency of our manufacturing equipment and processes.Key...

  • Process Engineer

    2 weeks ago

    Thousand Oaks, California, United States Actalent Full time

    Job Title: Process EngineerActalent is seeking a highly skilled Process Engineer to join our team in Thousand Oaks, CA. As a Process Engineer, you will play a critical role in organizing Technology Transfer activities for Final Drug Product manufacturing.Key Responsibilities:Support Tech Transfer project scheduling activities for FDPSupport New Product...

  • Process Engineer

    2 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Process EngineerACL Digital is seeking a highly skilled Process Engineer to join our team. As a Process Engineer, you will play a critical role in supporting manufacturing activities associated with cGMP equipment and facilities.Key Responsibilities:Provide technical support to manufacturing and maintenance teamsDevelop and oversee the operation...

  • Senior Reliability Engineer

    2 weeks ago

    Thousand Oaks, California, United States Planet Pharma Full time

    Job Title: Senior Reliability EngineerPlanet Pharma is seeking a highly skilled Senior Reliability Engineer to join our team. As a key member of our manufacturing operations, you will be responsible for ensuring the reliability and efficiency of our equipment and processes.Responsibilities:Develop and implement reliability improvement projects to reduce...

  • Process Engineer

    1 month ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Process EngineerWe are seeking a highly skilled Process Engineer to join our team at ACL Digital. As a Process Engineer, you will play a critical role in supporting manufacturing activities associated with cGMP equipment and facilities.Key Responsibilities:Develop and oversee the operation and reliability of equipment while driving safety and...

  • Senior Reliability Engineer

    2 weeks ago

    Thousand Oaks, California, United States SSi People Full time

    Job Title: Senior Reliability EngineerLocation: Thousand Oaks, CAPay Rate: $48/hr to $50/hrJob Summary:SSi People is seeking a Senior Reliability Engineer to join our team. As a key member of our engineering team, you will be responsible for identifying, supporting, and leading the implementation of engineering-based improvements or upgrades to equipment or...

  • Director of Biologics Process Development

    3 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Transforming Biologics DevelopmentAmgen is seeking a visionary Director of Biologics Process Development to spearhead the development of commercial formulations and drug product processes for our biologics pipeline. As a key member of the Pivotal Biologics leadership team, you will provide scientific, technical, and managerial leadership to drive innovation...

  • Biopharmaceutical Manufacturing Associate

    2 weeks ago

    Thousand Oaks, California, United States Actalent Full time

    Job SummaryThe Manufacturing Associate will work in a dynamic production environment supporting development, clinical, and launch activities. Under general supervision, the employee will perform operations in the Manufacturing area, adhering to Standard Operating Procedures (SOPs).Key Responsibilities:Perform hands-on operations, including set-up, cleaning,...

  • Senior Reliability Engineer

    4 weeks ago

    Thousand Oaks, California, United States Infotree Global Solutions Full time

    Job Title: Senior Reliability Engineer - GMP Equipment SpecialistWe are seeking a highly skilled Senior Reliability Engineer to join our team at Infotree Global Solutions. As a key member of our engineering team, you will be responsible for ensuring the reliability and safety of our GMP equipment and facilities.Key Responsibilities:Develop and implement...

  • Principal Manufacturing Systems Engineer

    5 days ago

    Thousand Oaks, California, United States Amgen Full time

    Job SummaryWe are seeking a highly skilled Principal Manufacturing Systems Engineer to join our team at Amgen. As a key member of our manufacturing team, you will be responsible for ensuring the success of drug product manufacturing through the design, development, and delivery of innovative solutions.Key ResponsibilitiesDesign, develop, and deliver...

  • Process Development Engineer

    2 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Process Development EngineerLocation: Not SpecifiedDuration: Not SpecifiedWe are seeking a highly skilled Process Development Engineer to join our Drug Substance Technology Engineering team. The successful candidate will provide process engineering support for human therapeutic products in clinical development through commercial production.The...

  • Process Development Engineer

    2 weeks ago

    Thousand Oaks, California, United States Analysts Full time

    Job DescriptionInnova Solutions is seeking a highly skilled Process Development Engineer to join their team. The ideal candidate will have a strong background in biologics engineering, with experience in purification processes and equipment. The successful candidate will be responsible for providing process engineering and technology transfer support for...