Process Development Engineer

2 days ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Engineer

Live

What you will do

Lets do this Lets change the world

Part of Amgens Process Development (PD) organization, Drug Product Technologies (DPT) is seeking a highly motivated Engineer to provide process development support to Amgens parenteral biologics fill-finish manufacturing plant in Thousand Oaks, CA. The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in technology transfer, product and process characterization, process validation and continuous process verification. A focus on visual inspection compliance and process optimization is a major expectation within this role.

Key Responsibilities:

  • Engage in the new product introduction (NPI) and ongoing manufacturing activities to enable and optimize our manual visual inspection (MVI) processes for an expanding product portfolio, including make-a-batch exercises, technical assessments, and designing and performing hands-on inspectability studies with inspectors.

  • Support the establishment of robust tactical and strategic objectives related to visual inspection, with emphases on the evolving state of regulatory expectations and alignment within the Amgen global network.

  • Provide PD expertise for drug product visual inspection triages and investigations, including but not limited to defect identification, maintenance of defect libraries, defect rate excursions, and forensics investigation of unknown defects.

  • Support the introduction of automated visual inspection (AVI) technology into the plant.

  • Generate, maintain, and optimize defect kits for training MVI operators, performing MVI studies, and developing AVI recipes.

  • Author, review, and data verify technical documents for all the above responsibilities per good documentation practices.

  • Provide subject matter expert guidance to regulatory submissions, responses to agency questions, and technology transfers to other Amgen plants.

  • Participate in knowledge management and dissemination activities to bolster MVI and AVI knowledge across the enterprise.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

    Basic Qualifications:

  • High school diploma / GED and 8 years of Engineering experience OR

Associates degree and 6 years of Engineering experience OR

Bachelors degree and 2 years of Engineering experience OR

Masters degree

Preferred Qualifications:

Degree in engineering, chemistry, physics, life sciences, or related field.

Experience in the pharmaceutical or biotechnology industry, including knowledge of Quality systems and current good manufacturing practice (CGMP) regulations.

Professional experience that includes elements of visual inspection within a manufacturing process.

The ability to learn and act upon dynamic information at a rapid pace in a multi-functional team environment.

Proficiency in technical problem solving, critical thinking, and the delivery of value-adding solutions with limited oversight and technical direction.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

  • Process Development Engineer

    1 day ago

    Thousand Oaks, California, United States US Tech Solutions Full time

    Job SummaryWe are seeking a highly skilled Process Development Engineer to join our Drug Substance Technology Engineering team at our Thousand Oaks facility. As a key member of our team, you will provide process engineering support for human therapeutic products in clinical development through commercial production.About the RoleThe successful candidate will...

  • Process Development Engineer

    11 hours ago

    Thousand Oaks, California, United States EPITEC Full time

    Job Title: Process Development EngineerLocation: Thousand Oaks, CA, USA - ONSITEJob Description:We're seeking a skilled Process Development Engineer to support the development of human therapeutic products in clinical development through commercial production at our Thousand Oaks facility. As a key member of the Drug Substance Technology Engineering team,...

  • Process Development Engineer

    21 hours ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Process Development EngineerLocation: Thousand Oaks, CADuration: 12+ MonthsDescription:We are seeking a highly skilled Process Development Engineer to join our team at ACL Digital in Thousand Oaks, CA. As a key member of our Drug Substance Technology Engineering team, you will provide process engineering support for human therapeutic products in...

  • Process Development Engineer

    1 week ago

    Thousand Oaks, California, United States EPITEC Full time

    Job Title: Process Development EngineerJob Summary:We are seeking a highly skilled Process Development Engineer to join our team at EPITEC. As a key member of our Drug Substance Technology Engineering team, you will play a critical role in providing process engineering support for human therapeutic products in clinical development through commercial...

  • Process Development Engineer

    16 hours ago

    Thousand Oaks, California, United States EPITEC Full time

    Job Title: Process Development EngineerLocation: Thousand Oaks, CA, USA - ONSITEJob Description:We are seeking a skilled Process Development Engineer to join our Drug Substance Technology Engineering team at our Thousand Oaks facility. The successful candidate will provide process engineering support for human therapeutic products in clinical development...

  • Process Development Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Engineer Location: Thousand Oaks, CADuration: 12 months Description:Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.The Engineer will...

  • Process Development Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Engineer Location: Thousand Oaks, CADuration: 12 months Description:Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.The Engineer will...

  • process development Engineer

    4 weeks ago

    Thousand Oaks, United States Belcan Full time

    process development Engineer Job Number: 351401 Category: Biomedical Engineering Description: Job Title: process development Engineer Location: Thousand Oaks, CA ZIP Code: 91320 Start Date: Right Away Keywords: #processdevelopmentEngineer Benefits: * Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses...

  • Process Development Engineer

    4 days ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...

  • Process Development Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Process Development EngineerLocation: Thousand Oaks, CA/HybridDuration: 12 MonthsDescription:ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CATop 3 Must Have Skill Sets: Purification experience, manufacturing experience, engineering experienceExperience with technical trouble shooting skillsSTRONG communication - must be comfortable speaking to a group...

  • Process Development Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Process Development EngineerLocation: Thousand Oaks, CA/HybridDuration: 12 MonthsDescription:ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CATop 3 Must Have Skill Sets: Purification experience, manufacturing experience, engineering experienceExperience with technical trouble shooting skillsSTRONG communication - must be comfortable speaking to a group...

  • Process Development Engineer- Monoclonal Purification

    1 month ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Ideal Candidate: 2-4 years of relevant experience working in drug and animal cells. Strong process knowledge. Experience purifying cells (biologics purifications), drug substance GMP manufacturing.ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CASTANDARD BUSINESS HOURS- SOME AFTER HOUR SUPPORTSeeking a Process Development Engineer to join the Drug...

  • Process Development Engineer- Monoclonal Purification

    1 month ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Ideal Candidate: 2-4 years of relevant experience working in drug and animal cells. Strong process knowledge. Experience purifying cells (biologics purifications), drug substance GMP manufacturing.ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CASTANDARD BUSINESS HOURS- SOME AFTER HOUR SUPPORTSeeking a Process Development Engineer to join the Drug...

  • Senior Process Development Engineer

    5 days ago

    thousand oaks, United States Infotree Global Solutions Full time

    Description:Related Activities:Participate or lead, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.Provide ad...

  • Senior Process Development Engineer

    5 days ago

    thousand oaks, United States Infotree Global Solutions Full time

    Description:Related Activities:Participate or lead, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.Provide ad...

  • Senior Process Development Engineer

    6 days ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Related Activities:Participate or lead, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.Provide ad...

  • Senior Process Development Engineer

    6 days ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Related Activities:Participate or lead, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.Provide ad...

  • Process Engineer

    3 months ago

    Thousand Oaks, United States ACL Digital Full time

    Title:Engineer (Process Engineer) Location: Thousand Oaks, CA 91320 Duration: 12+ Months Description: ONSITE 3-4 DAYS A WEEK AT THOUSAND OAKS CA STANDARD BUSINESS HOURS- SOME AFTER HOUR SUPPORT Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support...

  • Process Development Engineer

    3 days ago

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

    Job Summary: We are seeking a highly skilled Process Development Engineer to join our Drug Substance Technology Engineering team at Infotree Global Solutions. The successful candidate will provide process engineering support for human therapeutic products in clinical development through commercial production.Key Responsibilities:Apply cell culture and/or...

  • Process Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title – Engineer (Upstream) Location – Thousand Oaks, CA Duration: 12 Months Description:Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission...