Senior Process Engineer, Manufacturing, Science, and Technology (MSAT) Cell Therapy

We need to output HTML fragment with sections: About the role (position summary), Responsibilities, Requirements (maybe Qualifications), Skills, Benefits, Pay, Schedule? The posting includes travel, on-call rotation, etc. We need to include sections only if real content. We must not repeat job title as heading. Use

for each section heading. We need to preserve all substantive info, no boilerplate. We need to remove cookie/navigation/legal/EEO etc. Also remove duplicated lines, application instructions. We need to include Pay section because posting states annual base pay range. Also Benefits section because they mention benefits. Schedule? Not explicit schedule but travel and on-call rotation maybe considered schedule? The instruction: include Schedule section only if posting actually states them. It mentions travel up to 15% domestic and international, on-call rotation during engineering/PPQ/critical campaigns. That's not exactly schedule but could be considered schedule? Might be considered "Travel" but not a separate heading. The allowed headings list includes Schedule. Since they didn't give regular work hours, we might omit Schedule. However they gave travel and on-call rotation; maybe we could put that under Responsibilities or a separate section like "Travel & On-call". But only allowed headings are those listed; we should not invent new headings. So we can include travel info under Responsibilities or maybe under a generic "About the role". Probably better to include under Responsibilities as part of duties. We need sections: About the role (position summary), Responsibilities, Requirements (maybe Qualifications), Skills, Benefits, Pay. We need to use

• for any list of duties/requirements/benefits. So we should convert responsibilities list into
  . Also qualifications list into
  . Skills list into
  . Benefits list into
  . Pay maybe just a

  . We must not repeat job title as heading. So no heading for Senior Process Engineer. We need to preserve all substantive info: location, travel, position summary, responsibilities details, qualifications, technical skills, soft skills, preferred qualifications, work environment, travel, on-call rotation, pay range, benefits, date posted, closing date? The instructions: remove duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, application instructions. Date posted and closing date maybe considered metadata; could be folded into a short

  or drop it. The instruction: do NOT put Job ID/requisition numbers as headings — fold minor metadata into a short

  or drop it. So we can include a short

  for date posted and closing date maybe. We must not invent or summarize away detail. So we need to keep specifics like pay range numbers, benefits list, etc. Let's extract content. Position Summary paragraph: "We are seeking an experienced Senior Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team at AstraZeneca’s Rockville, MD cell therapy manufacturing facility. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products." We can put that under About the role. Responsibilities: many bullet-like sentences. We'll list them as

  • . We need to capture all responsibilities: - Site manufacturing support - Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required) - Operations Support: Represent Site MS&T function at site 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 multi-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 or co-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 multi-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 supply to second-source strategies - Automation: Partner with automation/digital manufacturing teams to implement electronic batch record improvements - Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure alignment to cGMP/ATMP requirements and data integrity principles (ALCOA+). - Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; chip in to lessons-learned, playbooks, and guidelines 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 - Chip in to technology transfer packages (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 on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required). - Multi-functional Collaboration - 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 list each as separate
  • . Might be long but okay. Requirements (Qualifications): Minimum Education and experience: B.S. with 8+ years of hands-on industry experience. M.S. with 4 years of hands-on industry experience, PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience Technical Skills: list bullet points. Soft Skills: list bullet points. Preferred Qualifications: list bullet points. Work Environment: On-site in Rockville, MD Ability to travel ~15% to other manufacturing facilities On-call rotation during engineering/PPQ/critical campaigns We could put travel and on-call under Work Environment or maybe under Responsibilities. Since we have no specific heading for Travel, we could include under Work Environment as a

    or

    . But we need to follow allowed headings; Work Environment is not in list. So we need to fold that info into a short

    or drop it. The instruction: "do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

    or drop it." Travel and on-call could be considered minor metadata? Might be okay to include in a short

    under maybe About the role or Responsibilities. But we need to preserve all substantive information. Travel and on-call are substantive. We could include them under Responsibilities as part of duties (e.g., "Ability to travel up to 15% domestic and international; on-call rotation during engineering/PPQ/critical campaigns"). Thus we can add a responsibility item for travel and on-call. Benefits: "Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans." We'll list benefits as

    . Pay: "The annual base pay (or hourly rate of compensation) for this position ranges from $103,286.40 to $154,929.60." We'll put that in a

    under Pay heading. Date Posted and Closing Date: we can include a short

    maybe under a generic metadata section but not a heading. Could add a

    at end: "Posted: 22-Sep-2026 | Closing: 15-Oct-2026". That's minor metadata. We must not include EEO boilerplate etc. Now produce HTML fragment. Structure:

    About the role

    ...

    Responsibilities

    • ...
    ...

    Requirements

    • ...
    ...

    Skills

    Maybe split into Technical Skills and Soft Skills? But we only have one Skills heading allowed. Could combine both technical and soft skills under Skills. Or we could have two sections: Skills and maybe another heading like "Technical Skills" not allowed. So we combine. Thus under Skills we list both technical and soft skills as
    • .

      Benefits

      • ...
      ...

      Pay

      The annual base pay (or hourly rate of compensation) for this position ranges from $103,286.40 to $154,929.60.

      Then maybe a

      for metadata. Make sure no extra text. Let's craft. Be careful to preserve all details: include location Rockville, MD in About the role? Already in summary. Could add location explicitly. Let's write About the role paragraph: combine position summary and location. "We are seeking an experienced Senior Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team at AstraZeneca’s Rockville, MD cell therapy manufacturing facility. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products." Now responsibilities list: need to capture each bullet. I'll create list items: - Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required) - Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities - Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and multi-functional alignment - Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes - Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data - Identify, justify, and implement continuous improvements by shepherding changes through multi-functional change controls with appropriate risk assessments and comparability - Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and support second-source strategies - Partner with automation/digital manufacturing teams to implement electronic batch record improvements - Author and revise batch records, SOPs, and technical reports; protocols, summary reports; ensure alignment to cGMP/ATMP requirements and data integrity principles (ALCOA+) - Deliver operator training on critical process steps or process changes; contribute to lessons-learned, playbooks, and guidelines across sites - Draft and review CMC sections (Module 3) in response to agency questions; support health authority and internal audits/inspections - Draft and review risk assessments and comparability study designs - Contribute to technology transfer packages (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; draft sections of PPQ protocols/reports - Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required) - Serve 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