Amgen
Overview
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Senior Process Development Engineer at Amgen. The role is part of Amgen’s Process Development organization, Drug Product Technologies (DPT), supporting Amgen's clinical and commercial sterile fill-finish manufacturing at Thousand Oaks, CA (ATO). The candidate will contribute to aseptic processing, technology transfer, process characterization, process validation and continuous process verification. Periodic shift work or on-call work is required.
Responsibilities
New Product Introductions: Lead or support new product introductions and lifecycle changes at Amgen Thousand Oaks, integrating product process design with site procedures; serve as the Process Development SME after tech transfer.
Collaboration: Work with multiple plant functions to characterize aseptic fill-finish equipment and procedures to enable efficient tech transfers of clinical and commercial products.
Process Knowledge: Act as point of contact for knowledge of site process capabilities and practices.
Make-a-Batch: Support make-a-batch exercises to assess facility fit and identify gaps.
DP Characterization: Design, implement and document off-line and on-site DP characterization studies.
PPQ Runs: Plan and provide floor support for engineering, machinability, and process performance qualification runs for product commercialization.
Documentation: Author and own high-quality process transfer and other technical documents.
Process Validation & Regulatory Support: Develop validation plans and support execution of PPQs for commercial manufacturing; author and review validation protocols, assessments and reports within Amgen’s quality systems.
Regulatory Standards: Ensure site process validation adheres to global regulatory standards and Amgen quality requirements; support regulatory filings and inspections as needed.
Manufacturing Support: Provide front-line process development expertise for clinical and commercial sterile drug product manufacturing, including processing, characterization, tech transfer, validation and ongoing operations.
Deviations & CAPA: Lead or assist in deviations, root cause analysis and CAPA for continuous operation and supply.
Risk & Quality: Apply science-based methodologies to identify root causes and justify decisions with evidence; conduct risk assessments and implement CAPAs.
Cross-Functional Collaboration: Partner with engineering, quality and drug product technologies to provide robust manufacturing support.
Process Improvements: Identify and implement improvements for current and new sterile operations to enhance reliability, agility and efficiency.
FMEAs & Documentation: Participate in FMEAs and risk assessments; prepare technical protocols, reports and regulatory filing subsections; present findings and project status.
Aseptic DP Technology Leadership: Serve as SME for new DP manufacturing technologies, drive innovations and align with regulatory expectations; document data packages for technology development.
Expansion Projects: Support equipment user requirements, FAT, characterization and validation in sterile fill-finish areas.
DP Network Support: Build relationships across DP Manufacturing network to share best practices and coordinate manufacturing processes.
Single Point of Contact: Guide drug product teams on site capabilities for freezing/thawing, formulation, filling, lyophilization and visual inspection.
What We Expect Of You We are diverse and value unique contributions. The successful candidate will have the following qualifications.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of Engineering and/or Operations experience OR
Bachelor's Degree and 4 years of Engineering and/or Operations experience OR
Associate's degree and 8 years of Engineering and/or Operations experience OR
High school diploma/GED and 10 years of Engineering and/or Operations experience
Preferred Qualifications
Advanced degree in engineering, biotechnology, life sciences or related field
4+ years in pharmaceutical/biotechnology industry with process development, characterization and tech transfers
Experience leading functional area deliverables with measurable business impact; ability to lead in dynamic manufacturing environments
Expertise in characterization of processes such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection
Project management skills and ability to manage multiple projects
Leadership of multi-functional teams, ability to drive projects to completion
Ability to lead innovation and collaborate; independent design and execution of characterization studies
Strong problem solving, communication and documentation skills; GMP knowledge
What You Can Expect From Us Amgen offers a comprehensive Total Rewards Plan with benefits, bonuses where eligible, and flexible work arrangements where possible. The company values an inclusive environment and equal opportunity employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected basis.
Application details and deadlines vary by region. Amgen is an Equal Opportunity employer and provides reasonable accommodations in recruitment, hiring and interview processes upon request.
#J-18808-Ljbffr
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Senior Process Development Engineer at Amgen. The role is part of Amgen’s Process Development organization, Drug Product Technologies (DPT), supporting Amgen's clinical and commercial sterile fill-finish manufacturing at Thousand Oaks, CA (ATO). The candidate will contribute to aseptic processing, technology transfer, process characterization, process validation and continuous process verification. Periodic shift work or on-call work is required.
Responsibilities
New Product Introductions: Lead or support new product introductions and lifecycle changes at Amgen Thousand Oaks, integrating product process design with site procedures; serve as the Process Development SME after tech transfer.
Collaboration: Work with multiple plant functions to characterize aseptic fill-finish equipment and procedures to enable efficient tech transfers of clinical and commercial products.
Process Knowledge: Act as point of contact for knowledge of site process capabilities and practices.
Make-a-Batch: Support make-a-batch exercises to assess facility fit and identify gaps.
DP Characterization: Design, implement and document off-line and on-site DP characterization studies.
PPQ Runs: Plan and provide floor support for engineering, machinability, and process performance qualification runs for product commercialization.
Documentation: Author and own high-quality process transfer and other technical documents.
Process Validation & Regulatory Support: Develop validation plans and support execution of PPQs for commercial manufacturing; author and review validation protocols, assessments and reports within Amgen’s quality systems.
Regulatory Standards: Ensure site process validation adheres to global regulatory standards and Amgen quality requirements; support regulatory filings and inspections as needed.
Manufacturing Support: Provide front-line process development expertise for clinical and commercial sterile drug product manufacturing, including processing, characterization, tech transfer, validation and ongoing operations.
Deviations & CAPA: Lead or assist in deviations, root cause analysis and CAPA for continuous operation and supply.
Risk & Quality: Apply science-based methodologies to identify root causes and justify decisions with evidence; conduct risk assessments and implement CAPAs.
Cross-Functional Collaboration: Partner with engineering, quality and drug product technologies to provide robust manufacturing support.
Process Improvements: Identify and implement improvements for current and new sterile operations to enhance reliability, agility and efficiency.
FMEAs & Documentation: Participate in FMEAs and risk assessments; prepare technical protocols, reports and regulatory filing subsections; present findings and project status.
Aseptic DP Technology Leadership: Serve as SME for new DP manufacturing technologies, drive innovations and align with regulatory expectations; document data packages for technology development.
Expansion Projects: Support equipment user requirements, FAT, characterization and validation in sterile fill-finish areas.
DP Network Support: Build relationships across DP Manufacturing network to share best practices and coordinate manufacturing processes.
Single Point of Contact: Guide drug product teams on site capabilities for freezing/thawing, formulation, filling, lyophilization and visual inspection.
What We Expect Of You We are diverse and value unique contributions. The successful candidate will have the following qualifications.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of Engineering and/or Operations experience OR
Bachelor's Degree and 4 years of Engineering and/or Operations experience OR
Associate's degree and 8 years of Engineering and/or Operations experience OR
High school diploma/GED and 10 years of Engineering and/or Operations experience
Preferred Qualifications
Advanced degree in engineering, biotechnology, life sciences or related field
4+ years in pharmaceutical/biotechnology industry with process development, characterization and tech transfers
Experience leading functional area deliverables with measurable business impact; ability to lead in dynamic manufacturing environments
Expertise in characterization of processes such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection
Project management skills and ability to manage multiple projects
Leadership of multi-functional teams, ability to drive projects to completion
Ability to lead innovation and collaborate; independent design and execution of characterization studies
Strong problem solving, communication and documentation skills; GMP knowledge
What You Can Expect From Us Amgen offers a comprehensive Total Rewards Plan with benefits, bonuses where eligible, and flexible work arrangements where possible. The company values an inclusive environment and equal opportunity employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected basis.
Application details and deadlines vary by region. Amgen is an Equal Opportunity employer and provides reasonable accommodations in recruitment, hiring and interview processes upon request.
#J-18808-Ljbffr