Jobs · Engineering · Illinois

Director, Engineering, Technical Expert Sterile Fill

BioSpace · North Chicago, IL · 1 mo ago
EngineeringFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes Company Description, Position Summary, Strategic Investments - Engineering Context, Key Responsibilities (with subheadings), Qualifications, Technical Competencies, Leadership Competencies, Working Relationships (maybe incomplete). We need to use

for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. But we must only include sections when posting has real specific content. The posting does not have Benefits, Pay, Schedule. So we should not include those headings. We need to map content to appropriate headings: "About the role" could be Position Summary? Or Company Description? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should use those exact headings when appropriate. We have content for About the role (maybe Company Description + Position Summary). Responsibilities (Key Responsibilities). Requirements (Qualifications). Skills (Technical Competencies + Leadership Competencies). Benefits, Pay, Schedule not present, so omit. We must not repeat job title as heading. No Job ID etc. We must preserve all substantive information, not invent or summarize away detail. Remove boilerplate etc. We need to output only HTML fragment, no /, no markdown fences. We need to use
  • for any list of duties/requirements/benefits, and

    for prose. We need to decide how to structure lists: The responsibilities have bullet-like paragraphs each starting with a bold heading? Actually the text includes headings like "Strategic Investments - Engineering Governance and Standards" then paragraphs. We could treat each as a list item under Responsibilities. Similarly Qualifications could be list items. We need to preserve all substantive information: So we need to include all details from the posting, but we can format as lists. We must not create filler sections. Let's extract content: Company Description: "About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube." We need to clean up: remove extra spaces, fix URLs? Probably keep as is but maybe add spaces: "www.abbvie.com". The original had no space after at. We'll keep as given? Might be okay. Position Summary: "The Director Engineering Technical Expert Sterile Fill provides enterprise-level technical leadership for sterile fill engineering across AbbVies strategic investment portfolio, with accountability for biologics sterile filling, Annex 1-aligned contamination control, aseptic processing design, barrier technology strategy, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance within Strategic Investments - Engineering. The role shapes and governs engineering strategies for strategic investments by setting technical direction, aligning standards and assuring robust execution across priority capital programs, technology platforms and future manufacturing capabilities. The role leads engineering activities associated with strategic investment programs, including new facility investments, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and capability-building initiatives that materially impact long-term business performance. The role partners with Strategic Investments leadership, operating sites, quality, EHS, validation / CQV and external engineering partners to make high-quality technical decisions, resolve complex risks and deliver business-aligned engineering outcomes." Strategic Investments - Engineering Context: paragraphs. Key Responsibilities: multiple sub-sections each with paragraphs. We need to turn each sub-section into list items? Could be each bullet as

  • containing the paragraph(s). Probably each subheading is a responsibility area; we can make each as
  • with the heading bold? But we cannot add extra tags beyond

    ,
      ,
    • ,

      . We could put the heading inside

    • as plain text, then a

      inside? But only allowed

      • for list, and

        for prose. We could do

      • ...

      • . The heading could be part of the

        . That's okay. Thus for Responsibilities, we create

          with each responsibility area as
        • ...text...

        • . Similarly Qualifications: list items. Skills: maybe combine Technical Competencies and Leadership Competencies into a single Skills section with list items. We must not invent headings like "Technical Competencies" as

          ; we only use the allowed headings. So Skills heading

          Skills

          and then list items. We need to ensure we include all substantive info. Let's extract each piece. I'll copy the text and parse. Company Description paragraph: "About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube." We could split into

          under About the role? Actually About the role could include Company Description and Position Summary. But we might separate: About the role could be Position Summary only. Company Description maybe not needed? But we must preserve ALL substantive information. So we need to include Company Description somewhere. Could be part of About the role section as a preceding paragraph. Thus About the role section:

          About the role

          then

          Company Description...

          Position Summary...

          . Now Responsibilities: we need to list each responsibility area. Let's extract each responsibility area text: 1. Strategic Investments - Engineering Governance and Standards Paragraph: "Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics sterile fill engineering, Annex 1-aligned contamination control strategy, aseptic processing, barrier technologies, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance.Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.Ensure discipline strategies directly support AbbVies strategic investment priorities, future manufacturing capability requirements and major capital program objectives.Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact." We need to keep the text as is, maybe add spaces after periods? We'll keep. 2. Strategic Investment Leadership and Execution Support Paragraph: "Provide senior engineering leadership for strategic capital investments, including new facility builds, technology platform deployments, capacity projects, infrastructure enablement, lifecycle asset renewal and future capability investments.Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site / platform planning activities.Partner with Strategic Investments and project leadership to ensure technical assumptions, deliverables, risks and resource needs are integrated into capital program plans.Apply enterprise lessons learned and strategic investment standards to improve project quality, decision speed, reliability and readiness across the portfolio." 3. Sterile Filling, Biologics Manufacturing and Annex 1 Compliance Paragraph: "Provide senior technical leadership for sterile filling of biologics and parenteral products, including vial, syringe, cartridge and bulk sterile transfer interfaces where relevant to strategic investment scope.Ensure facility, equipment and process design decisions are aligned with EU GMP Annex 1 expectations for sterile medicinal products, including contamination control strategy, quality risk management, cleanroom classification, barrier technology and aseptic process control.Govern technical strategy for isolators, restricted access barrier systems, Grade A critical zones, Grade B / C / D background environments, unidirectional airflow, first-air protection, glove systems, transfer systems and aseptic interventions.Lead engineering input to contamination control strategy development, ensuring critical control points are embedded across facility design, equipment, utilities, personnel flows, material flows, cleaning, disinfection, environmental monitoring and maintenance access.Partner with Quality, MS&T, Validation / CQV and Operations to ensure aseptic process simulations, media fill strategy, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring and viable / non-viable particle control are considered in design and readiness decisions.Provide technical challenge and risk-based decision support for interventions, line set-up, lyophilization interfaces, stopper / component handling, depyrogenation, sterilization, single-use systems, CIP / SIP interfaces and biologics product protection requirements.Ensure sterile fill investment programs are designed for inspection readiness, robust contamination prevention, operational maintainability, product sterility assurance and reliable long-term biologics manufacturing performance." 4. Technical Leadership and Delivery Paragraph: "Lead technical decision-making for biologics sterile fill engineering, aseptic processing design, Annex 1 compliance expectations, contamination control strategy, barrier technology selection, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance across strategic investment programs and technology platforms.Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness.Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders.Drive timely resolution of technical issues and ensure disciplined escalation when decisions have material project, portfolio, enterprise or business impact." 5. Cross-Functional Integration Paragraph: "Partner with Strategic Investments, manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain, finance and related engineering disciplines.Ensure discipline decisions are integrated with strategic investment objectives, manufacturing strategy, capacity planning, technology platform deployment, regulatory expectations and site handover needs.Facilitate collaboration across regions, sites and project teams to avoid fragmented solutions and drive consistency across strategic investments.Represent Strategic Investments - Engineering in technical reviews, project forums and risk discussions relevant to assigned scope." 6. Capability Building and Continuous Improvement Paragraph: "Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects.Build capability through coaching, mentoring, technical review discipline and development of reusable engineering practices.Promote a culture of engineering excellence, safety, quality, reliability, collaboration, accountability and proactive risk management.Support continuous improvement of Strategic Investments - Engineering standards, templates, knowledge management and project delivery approaches." 7. Strategic Investments - Engineering Leadership Expectations Paragraph: "Collaborate across the enterprise engineering community to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives.Promote consistency, quality, reliability, sustainability and project delivery performance across the strategic investment portfolio.Support long-range strategic investment planning, manufacturing strategy and future capability development.Build technical capability through coaching, mentoring, standards governance, knowledge management and cross-functional collaboration." 8. Stakeholder Interfaces Paragraph: "Strategic Investments:Investment planning, portfolio alignment, technical assumptions, front-end engineering, strategic capital program support and executive decision enablement. Manufacturing Sites and Operations:Network needs, site readiness, operability, maintainability, startup, handover and operational performance support. Quality, Validation / CQV and EHS:Compliance expectations, validation strategy, qualification readiness, safety, risk review and inspection readiness interfaces. Strategic Investments - Engineering Disciplines:Cross-discipline technical integration, standards, design reviews, technical issue resolution and strategic investment lessons learned. External Engineering Partners, EPCM Firms, Vendors and OEMs:Technical oversight, deliverable review, issue escalation, supplier alignment and execution quality." Now Qualifications: we have paragraphs: "Bachelors degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred where relevant.Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience.Demonstrated technical capability in biologics sterile filling, aseptic processing, Annex 1 contamination control expectations, isol

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