Are you ready to lead the charge in transforming drug product manufacturing? As a Senior Manager, Process Engineering, you'll spearhead the technical strategy and execution within an aseptic sterile fill-finish facility. This pivotal role demands a focus on AI-enabled and digital strategies, lean transformation, and financial performance to ensure reliable, compliant, and cost-effective operations. You'll manage process and equipment lifecycle, drive continuous improvement across various manufacturing processes, and facilitate seamless product transfers and format expansions. Collaborate with cross-functional teams and develop a high-performing team of process engineers and maintenance technicians to achieve excellence.

Accountabilities:
• Strategy & Leadership: Define and execute the DP process engineering strategy aligned to business objectives, integrating AI, digital technologies, and lean principles to improve safety, compliance, throughput, cost, and quality.
• AI & Digital Enablement: Lead the deployment of advanced analytics, statistical process control, machine learning for predictive quality/maintenance, electronic batch record enhancements, recipe/configuration management, and dashboarding to elevate decision-making and process robustness.
• Lean Transformation: Own and drive lean culture within DP Engineering Operations, including 5S, Standard Work, TPM, visual management, value stream mapping, and Kaizen. Use FMEA, and structured problem-solving to achieve measurable improvements in yield, scrap, OEE, cycle time, and right-first-time.
• Financial Delivery: Develop and manage the DP Engineering Operations budget; build business cases and capital expenditure requests (CERs); deliver OPEX savings; track financial KPIs (e.g., cost per unit, maintenance spend) and ensure projects meet cost, schedule, and functionality targets.
• Technical Ownership: Provide technical leadership and ownership of process equipment and utilities across the aseptic fill-finish facility, ensuring equipment design meets user requirements and regulatory expectations. Drive equipment upgrades, retrofits, remediation, and innovation.
• NPI & Transfers: Act as a key contributor/leader for DP NPIs and product transfers. Own recipe development, format management, and testing to support commercial range expansion and feature enhancement.
• Compliance & Quality: Ensure alignment to GMP, HPRA, FDA, data integrity, and Health & Safety regulations. Champion a safe, compliant culture and foster right-first-time execution across engineering operations.
• Vendor & Stakeholder Management: Serve as the client point of contact for equipment and system vendors. Lead structured issue resolution, negotiation, and delivery assurance. Partner closely with Operations, Quality, Validation, Supply Chain, IT/Digital, and Finance to enable smooth transitions from project to steady state.
• Performance & Reporting: Establish and track KPIs for safety, quality, service, OEE, yield, maintenance effectiveness, energy/utilities usage, and financial performance. Provide transparent reporting to stakeholders, SLT, and in tier meetings.
• Team Leadership & Development: Manage, mentor, and coach a team of process engineers and maintenance technicians. Build capability in AI/digital tools, lean, and technical problem solving; create succession and development plans; promote a culture of continuous improvement and accountability.
• Issue Escalation & Troubleshooting: Lead complex technical investigations, product complaints, and RCA/CAPA execution related to equipment and processes; ensure timely, data-driven closure and sustained effectiveness.
• Representation: Represent Engineering Operations DP and the functional unit in cross-functional forums and, as needed, in the absence of the Associate Director, including SLT and tiered daily management meetings.

Essential Skills/Experience:
• Education: HETAC Level 8 qualification in pharmaceutical, chemical, mechanical engineering, or a related engineering field. Advanced degree preferred.
• Experience: Minimum of 8 years in technical engineering roles within Pharmaceutical/Biotechnology, including leadership of projects and teams in aseptic sterile manufacturing and fill-finish.
• Digital Savvy: Forward-thinking professional who leverages AI, data, and automation to drive measurable impact. Digitally savvy, fluent in modern tools and platforms, optimizing workflows and fostering innovation.

Desirable Skills/Experience:
• Technical Domains: Significant hands-on and leadership experience across media prep, buffer prep, formulation, sterile filtration, depyrogenation, autoclaves, vial filling, high-speed aseptic filling lines, and automated visual inspection.
• Lean/Six Sigma: Proficiency in lean (5S, Standard Work, TPM, VSM) and six sigma tools (DOE, SPC, FMEA); proven track record of delivering measurable operational improvements.
• Regulatory: Strong knowledge of GMP, HPRA/FDA requirements, and current Health & Safety regulations.
• Business & Financial Acumen: Ability to build business cases, manage budgets, deliver OPEX/CAPEX savings, and communicate financial impacts to stakeholders.
• Leadership & Collaboration: Excellent communication, stakeholder management, vendor management, and team leadership skills; ability to work independently and cross-functionally with minimal supervision.
• Analytical & Digital Skills: Well-developed analytical, numerical, and computer skills; ability to combine hands-on activities with theoretical knowledge and digital methods.

At AstraZeneca's Alexion division for Rare Diseases, you'll find an environment where innovation thrives. Our commitment to patients drives us to continuously adapt and act with urgency. Here you'll be part of a team that values diversity and inclusiveness while fostering connections that inspire new ideas. With a rapidly expanding portfolio in rare diseases, you'll have the autonomy to explore new avenues while contributing to meaningful change for underserved patients worldwide. Our culture celebrates integrity and collaboration as we strive to make a difference every day.

Ready to make an impact? Apply now to join our dynamic team!

Date Posted

24-Nov-2025

Closing Date

07-Dec-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Senior Manager, Engineering Operations Drug Product

Job Description