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Alexion

Global biopharmaceuticals focusing on rare diseases

Head of Automation & Digital Manufacturing

Full-TimeDeadline 10/30/26
No salary listed
Expert
Bachelor's, Master's
Dublin, Ireland
HybridA minimum of three days per week in the office is expected.
Electrical EngineeringControls & Automation Engineering

About the job

Requirements
  • A bachelor's degree in Automation, Electrical, Electronic, Computer, Software or Control Engineering, Computer Science, or a related discipline is required; an advanced degree is desirable.
  • Typically 10 or more years of relevant experience in GMP pharmaceutical, biopharmaceutical or similarly regulated manufacturing environments.
  • Substantial experience leading large automation, manufacturing systems, digital or OT teams, including direct people leadership of diverse teams of FTEs and outsourced service providers.
  • Demonstrated experience developing automation roadmaps, handling system lifecycles and delivering complex technology or capital programmes.
  • Experience handling budgets, suppliers, systems integrators and multidisciplinary stakeholders in a regulated environment.
  • Broad knowledge of PLC, MCS, MES, HMI, historian, industrial networks, Windows-based OT infrastructure, vision, motion control and manufacturing system integration.
  • Strong understanding of automation architecture, process control, compatibility, integration, security, cybersecurity and lifecycle management.
  • Working knowledge of cGMP, GAMP, computer system validation, data integrity, electronic records and signatures, change control and inspection readiness.
  • Ability to apply data, analytics, AI and digital technologies to engineering opportunities responsibly, compliantly and with value focus.
  • Strong project and programme management capability across planning, risk, schedule, budget, vendor governance and benefits realisation.
  • Connect technology, data and business trends to shape practical plans, priorities, investment decisions and measurable outcomes; understand Industry 4.0 trends and align site strategic plans with anticipated industry and regulatory changes.
  • Create actionable short- and long-term plans, anticipate risk, remove obstacles and build team capability to deliver.
  • Lead adoption of digital tools and practices while promoting responsible, secure and compliant use.
  • Communicate clearly, facilitate alignment and constructively influence stakeholders with different perspectives.
  • Identify barriers and enablers, lead structured change and remain resilient as priorities and technologies evolve.
  • Build inclusive teams and apply broad understanding across automation, process, maintenance, validation, projects and manufacturing operations.
  • Enable lean approaches by using data to identify and action process-efficiency improvements; lead risk- and data-based problem solving (level zero and PPS), drive proactive cross-area process interventions, and use the Tier process to manage daily operations, escalations and resource alignment as priorities change.
  • Connect to internal customers' needs, support short-term requirements and align on medium- and long-term priorities.
Responsibilities
  • Own and execute the site Automation, OT and Digital Manufacturing strategy, including multi-year roadmaps for capability, lifecycle, obsolescence, resilience, compliance, cybersecurity and investment.
  • Provide strategic and technical leadership for PLC, HMI, historian, Manufacturing Control Systems Delta V (MCS), Manufacturing Execution System (MES) interfaces, industrial networks, OT infrastructure and related manufacturing systems.
  • Establish and govern standards for automation architecture, integration, compatibility, configuration management, system ownership, documentation and technical decision-making.
  • Ensure manufacturing systems remain available, secure, supportable, validated and inspection-ready, with effective administration, access control, backup, recovery, on-call support and business continuity arrangements; provide 24/7 front-line support to manufacturing OT systems.
  • Develop flexible OT systems that adapt to future needs and enable a flexible multi-product manufacturing facility and seamless, accelerated introductions of new products to BDS and packaging operations.
  • Lead systemic resolution of complex automation issues through risk assessment, structured problem-solving, root cause analysis, investigations, change controls and effective corrective and preventive actions (CAPAs).
  • Own the site OT cybersecurity improvement plan with IT and global teams, including segmentation, privileged access, patching, vulnerability management, monitoring, incident response and recovery controls.
  • Identify and prioritize opportunities to use AI, analytics, predictive maintenance, digital twins and manufacturing intelligence to improve reliability, yield, cycle time, cost, energy performance and decision-making.
  • Ensure digital and AI solutions meet applicable validation, data integrity, security, ethical and GxP requirements, and build team capability through practical use cases, coaching and structured learning.
  • Lead automation and digital workstreams for capital projects, capacity expansions, equipment upgrades, technology transfers and new product introductions from concept through handover.
  • Approve automation strategies, architecture, functional requirements, vendor designs, testing approaches and lifecycle support models, ensuring delivery to agreed scope, schedule, cost, quality and compliance.
  • Lead strategic system integrator, supplier and original equipment manufacturer relationships, including technical performance, work execution, safety, risk and long-term support.
  • Develop and lead operating and capital budgets, workforce plans, external service strategies, business cases and key performance indicators for safety, quality, supply, cost, people, compliance, reliability, cybersecurity and digital adoption.
  • Lead, mentor and develop managers, engineers, specialists and partner resources; maintain clear goals, development plans, succession plans and targeted upskilling for critical capabilities.
  • Build strong multifunctional and global partnerships, communicate complex issues clearly, influence senior stakeholders and act as the senior site escalation point for critical automation and manufacturing systems events.
  • Maintain a safe and secure work environment and champion lean thinking, continuous improvement and sustainability opportunities enabled by automation and digital technology.
Desired Qualifications
  • An advanced degree in a relevant discipline.
  • Experience aligning standards and platforms across multiple manufacturing sites.
  • Proven deployment of AI, advanced analytics, predictive maintenance and digital twins at scale within validated GMP environments.
  • Experience leading automation scope on greenfield or brownfield capital expansions and major technology transfers.
  • Professional certifications in cybersecurity, automation or programme management, such as ISA/IEC, CISSP or PMP.

About the company

Alexion focuses on discovering, developing, and selling therapies for rare and ultra-rare diseases by targeting the complement system. Its drugs, such as Soliris and Ultomiris, inhibit C5 to block inflammatory cascades, while Strensiq and Kanuma treat metabolic and lysosomal disorders. The company combines in-house R&D with acquisitions to expand its portfolio and leverages AstraZeneca’s global scale to reach patients. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to international markets at premium pricing.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Boston, Massachusetts

Founded

1992

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Simplify's Take

What believers are saying

  • AstraZeneca's July 2026 half-year revenue rose 9%, driven partly by Alexion's rare-disease growth.
  • Ultomiris gained FDA Priority Review on June 15, 2026 for IgAN, with Q4 2026 decision.
  • Koselugo's November 2025 adult NF1 approval and ALXN2220 phase 3 expand the pipeline.

What critics are saying

  • EmblemHealth's April 2025 Soliris antitrust suit targets patent settlements and biosimilar delays.
  • Soliris faces biosimilar erosion after March 2025, while Ultomiris still depends on C5-franchise switching.
  • Ultomiris carries meningococcal boxed warnings; a single fatal infection can trigger litigation and prescribing pullback.

What makes Alexion unique

  • Alexion pioneered complement biology, turning C5 inhibition into approved medicines since Soliris, 2007.
  • Ultomiris, Soliris, Strensiq, and Koselugo span hematology, nephrology, endocrinology, and oncology-adjacent rare diseases.
  • AstraZeneca's 2021 acquisition gives Alexion global commercialization scale and deeper trial funding.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Disability Insurance
  • Health Savings Account/Flexible Spending Account
  • Unlimited Paid Time Off
  • Flexible Work Hours
  • Remote Work Options
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

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PR Newswire
Aug 23rd, 2024
Global Genes' Annual Week In Rare Event Heading To Kansas City

"Week in RARE provides advocates a unique opportunity to participate in multiple events in one place to maximize their time, travel, and potential to gain benefits from their participation."

StartupTicker
Apr 9th, 2024
Clinical Success For Neurimmune

Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases, has, in collaboration with its partner Alexion, advanced its drug candidate ALXN2220 into phase 3. This marks a significant step in the company’s journey to addressing the serious clinical condition ATTR-CM.  Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, systemic clinical condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis. Despite recent advances in slowing disease progression, there is currently no treatment available to deplete cardiac ATTR amyloid and revert cardiac dysfunction. Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases including Alzheimer’s disease, amyotrophic lateral sclerosis, frontotemporal dementia and ATTR cardiomyopathy, is currently testing a drug candidate, ALXN2220 (formerly NI006), a human antibody targeting ATTR Cardiomyopathy. In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca’s Rare Disease group, for ALXN2220. Neurimmune is responsible for completion of the phase 1b clinical study on behalf of Alexion, with Alexion incurring certain trial costs. Aside from the phase 1b trial, Alexion is responsible for further clinical development, manufacturing, and commercialization as ALXN2220. The two companies have now initiated the phase 3 of the DepleTTR-CM clinical study to assess the efficacy and safety of ALXN2220 for the treatment of ATTR-CM

Business Wire
Apr 1st, 2024
Voydeya™ Approved In The Us As Add-On Therapy To Ravulizumab Or Eculizumab For Treatment Of Extravascular Hemolysis In Adults With The Rare Disease Pnh

WILMINGTON, Del.--(BUSINESS WIRE)--VOYDEYA™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).1 VOYDEYA is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor.2,3. The approval by the US Food and Drug Administration (FDA) was based on positive results from the pivotal ALPHA Phase III trial. Results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology.2. Bart Scott, MD, Professor, Division of Hematology and Oncology at the University of Washington Medical Center, and Professor, Clinical Research Division at Fred Hutchinson Cancer Center, said: “The approval of VOYDEYA offers this small subset of PNH patients an add-on therapy designed to address EVH, while maintaining disease control with ULTOMIRIS or SOLIRIS. Terminal complement inhibition with ULTOMIRIS can address the life-threatening complications of PNH, building on the efficacy and safety of SOLIRIS established over nearly 20 years.”

Business Wire
Mar 25th, 2024
Ultomiris® (Ravulizumab-Cwvz) Approved In The Us For The Treatment Of Adults With Neuromyelitis Optica Spectrum Disorder (Nmosd)

WILMINGTON, Del.--(BUSINESS WIRE)--ULTOMIRIS® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).1. The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology.2 In the trial, ULTOMIRIS was compared to an external placebo arm from the pivotal SOLIRIS® PREVENT clinical trial. ULTOMIRIS met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Zero relapses were observed among ULTOMIRIS patients with a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p0.0001).2

PharmiWeb
Nov 28th, 2023
Nice Endorses Only Approved Treatment For Ultra-Rare Wolman Disease For Children Diagnosed Under The Age Of Two: Interview Opportunity

Sebelipase alfa (Kanuma®▼) recommended by NICE as the first treatment for infants with ultra-rare Wolman Disease.  . Kanuma, an enzyme replacement therapy, is the first medicine to be recommended for this life-threatening condition in infants under two years old