Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

We need to output HTML fragment only, with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Preserve all substantive info. Include a section only when posting has real specific content for it. Avoid filler like "commensurate with experience". Pay and Schedule sections only if posting actually states them. The posting includes pay range: "The annual base pay for this position ranges from $142,377.60 - $213,566.40." Also mentions hourly and salaried non-exempt employees overtime. Also mentions short-term incentive bonus, equity-based long-term incentive, retirement contribution, commission eligibility. Benefits: qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; health benefits including medical, prescription drug, dental, vision. Also mentions additional details. So we can have Benefits and Pay sections. Schedule: The posting mentions "When we put unexpected teams in the same room..." then "In-person working gives us the platform... That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility." Also mentions "On-site in Santa Monica and Tarzana, CA Ability to travel ~15% to other manufacturing facilities On-call rotation during engineering/PPQ/critical campaigns". So schedule info includes on-site expectation, travel, on-call rotation. So we can include a Schedule section with that content. We also need sections: About the role (maybe a brief summary), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title as heading. Use

  for each section heading. We need to preserve all substantive info. Let's extract. About the role: The first paragraph: "We are seeking an experienced Principal Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team. This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products. This role will oversee a team of engineers, with individual contributions that may include: leading technical support, developing technical instructions, procedures, and operator training content, performing data analysis and process performance trending, leading complex deviation investigations, leading implementation of CAPAs and continuous improvement through change controls, and contributing to validation and regulatory deliverables. These responsibilities will be exercised through the scope of supporting, technology transfer, clinical manufacturing, site readiness, process validation/PPQ, commercial manufacture readiness, and product lifecycle management activities." We can put that as About the role (maybe combine with responsibilities? But we need separate sections). We'll put About the role as a brief summary: the first two sentences maybe. But we must preserve all substantive info; we can split. Responsibilities: The bullet list after "Key Responsibilities" includes many items. We'll list them as

  • . The list includes: - Site manufacturing support - Manage, guide, and mentor MS&T engineer(s) - Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing, including managing on-the-floor support for critical campaigns (including occasional off-shift support where required) - Operations Support: Lead Site MS&T representation at operational tier meetings, providing collaborative inputs that drive site activities - Data trending and analysis: Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment. - Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. - Deviation/CAPA Support: Lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data. - Continuous improvements: Identify, justify, and implement continuous improvements by shepherding changes through cross‑functional change controls with appropriate risk assessments and comparability. - Raw materials: Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and contribute to second-source strategies - Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, manufacturing summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+). - Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; Develop and drive lessons-learned, playbooks, and best practices across sites. - Regulatory Contributions: Draft and review CMC sections (Module 3), response to agency question, support health authority and internal audits/inspections. - Technology Transfer & Process Validation: Draft and review risk assessments and comparability study design; Establish framework for New Product Introduction procedures and intake at the site; Lead technology transfer activities (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports; Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports; Provide and manage on the floor technical support during scale-out, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off-shift support when required). - Cross‑Functional Collaboration: Serve as site MS&T lead at CMC and functional governance meetings; Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory; Support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes. We'll capture these. Requirements: The posting has "Required Qualifications" section with education and technical skills and soft skills. We can split into Requirements (maybe education) and Qualifications (maybe experience). But the instruction says use headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content accordingly. We have education requirements: "Education PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 4+ years of industry experience; OR M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of industry experience OR B.S. with 10+ years of hands-on industry experience." Technical Skills: list of technical skills. Soft Skills: list. Preferred Qualifications: "Experience with late‑stage clinical manufacturing support of cell therapy products Experience with process validation and commercial readiness of cell therapy products" Work Environment: On-site in Santa Monica and Tarzana, CA Ability to travel ~15% to other manufacturing facilities On-call rotation during engineering/PPQ/critical campaigns We need to decide what goes where. Probably: - Requirements: Education (maybe also required years). Could also include required technical skills? But we have separate Skills heading. - Qualifications: Preferred qualifications? Or maybe "Qualifications" includes both required and preferred? The instruction says we have both Requirements and Qualifications headings. We need to decide distribution. We could put: Requirements: Education (the OR statements) and maybe required years? Actually education includes years. Qualifications: Preferred qualifications (late-stage clinical manufacturing support, process validation and commercial readiness) plus maybe work environment? But work environment maybe Schedule. Skills: Technical Skills and Soft Skills. Let's map: - About the role: introductory paragraph(s) describing role. - Responsibilities: the bullet list under Key Responsibilities. - Requirements: Education requirements (PhD/MS/BS with years). - Qualifications: Preferred qualifications (late-stage clinical manufacturing support, process validation and commercial readiness) maybe also "Experience with technology transfer" (mentioned earlier in ideal candidate). Actually ideal candidate: "The ideal candidate brings hands-on experience with cell therapy unit operations through previous experience in process development and/or manufacturing, as well as expertise in technology transfer. Experience with process validation and commercialization activities is desired." That could be part of Qualifications. - Skills: Technical Skills and Soft Skills. - Benefits: benefits description. - Pay: pay range and bonus etc. - Schedule: work environment, on-site expectation, travel, on-call rotation. We must not include boilerplate like EEO, diversity statement, date posted, closing date, mission statements, etc. We must preserve all substantive info: ensure we don't lose any details. Let's extract each piece. About the role: We'll take first two sentences maybe plus the sentence about overseeing a team? Actually that is part of responsibilities. But we can include a brief overview: "We are seeking an experienced Principal Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team. This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products. This role will oversee a team of engineers." That seems good. Responsibilities: We'll list all bullet items. Requirements: Education: "PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 4+ years of industry experience; OR M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of industry experience OR B.S. with 10+ years of hands-on industry experience." Qualifications: Preferred qualifications: "Experience with late‑stage clinical manufacturing support of cell therapy products", "Experience with process validation and commercial readiness of cell therapy products". Also maybe "Experience with technology transfer" and "Experience with process validation and commercialization activities is desired." We'll combine. Skills: Technical Skills: list: - Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment - Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations. - Proficiency with statistical analysis (including univariate, multi-variate analysis, control charts) - Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication - Strong data analysis, and problem‑solving skills. Soft Skills: - Excellent cross‑functional communication and collaboration. - Ability to translate complex data into clear decisions and regulatory-ready narratives. - Excellent problem solving, cross-functional leadership, and communication under time-sensitive conditions. Benefits: "Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans." Also mention short-term incentive bonus opportunity; eligibility to participate in equity-based long-term incentive program (salaried roles); to receive a retirement contribution (hourly roles); and commission payment eligibility (sales roles). Also mention additional details of participation will be provided if an employee receives an offer. Pay: "The annual base pay for this position ranges from $142,377.60 - $213,566.40. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles)." Actually some of that overlaps with benefits; but we can keep pay section focusing on base pay range and overtime, mention that base pay may vary. The bonus etc could be in Benefits but we already placed there. To avoid duplication, we could put bonus etc in Benefits. Pay section just base pay range and overtime note. Schedule: "On-site in Santa Monica and Tarzana, CA Ability to travel ~15% to other manufacturing facilities On-call rotation during engineering/PPQ/critical campaigns When we put unexpected teams