AstraZeneca
Process Engineer - Drug Substance Manufacture (DSM)
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Process Engineer - Drug Substance Manufacture (DSM)
Process Engineer – Macclesfield, UK
Introduction to the Role
Are you eager to transform complex chemical processes into robust, compliant manufacturing that delivers life-saving medicines more efficiently?
At AstraZeneca, we’re looking for a Process Engineer to join our Drug Substance Manufacture (DSM) team in Macclesfield, UK. In this role, you’ll drive process improvements, scale-up new technologies, and solve production challenges—ensuring our pharmaceutical manufacturing is safe, sustainable, and accelerated so patients receive critical treatments when needed.
Based in a world-class facility, you’ll collaborate across Production, QA, Engineering, Procurement, and suppliers to turn development ideas into measurable results. From authoring PEAR reports to leading root-cause analyses, you’ll have an immediate impact—growing into a key influencer in process design, validation, and long-term asset management.
Key Accountabilities
Process Improvement Delivery
- Collate and analyze production data to identify improvement opportunities
- Develop and implement compliant changes that increase capacity, robustness, reliability, and asset performance
- Drive data-driven innovations to enhance manufacturing efficiency
Scale-Up & Technology Introduction
- Partner with Drug Substance Manufacture and Global Engineering to introduce new technologies from pilot scale to full manufacture
- Reduce process variability and elevate throughput in high-growth areas
Process Accommodation & Compliance
- Lead pre-accommodation checks and author PEAR reports for safe, right-first-time process introduction
- Ensure alignment with GMP, GxP, SHE, and validation requirements throughout change life cycles
Risk & Change Management
- Maintain FMEA documents and deliver control plans to mitigate failure risks
- Contribute to process risk assessments for safe pilot-to-manufacturing transfers
- Act as Change Control Owner, ensuring full validation and compliance throughout
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Troubleshooting & Root Cause Analysis
- Prioritize urgent operational issues with structured problem-solving (e.g., 8D method)
- Identify root causes and implement corrective/preventive actions (CAPAs)
Regulatory & Inspection Support
- Ensure project processes and deliverables meet internal/external regulatory standards
- Provide technical expertise during inspections and manage asset transfers
Cross-Functional Collaboration
- Engage with Production, Engineering, QA, Supply Chain, Procurement, contractors, and suppliers
- Promote shared priorities, visual management, and standardized workflows
Financial Stewardship
- Adhere to financial policies and own requisitions/procurement processes
- Monitor budget compliance, cost tracking, and contract closures
Project & Stakeholder Management
- Oversee multiple concurrent projects, balancing regulatory, engineering, and business needs
- Minimize production downtime while maintaining high standards
Safety, Health & Environment (SHE) Leadership
- Foster a safe working environment across small molecule API, oligos/peptides, and linker chemistry
- Proactively use the SHE system to identify and mitigate hazards
Coaching & Team Development
- Share expertise, mentor peers, and cultivate a positive, high-performing culture
- Provide holiday/absence cover to ensure operational continuity
Essential Skills & Experience
- Degree in Chemical Engineering (or equivalent via apprenticeship with HNC/HND)—pharma experience preferred
- Data-driven mindset—ability to analyze process performance for improvement opportunities
- 3–5+ years of pharmaceutical industry experience in Development, Manufacture, or Capital Projects
- Strong comprehension of high-hazard material manufacturing (SHE risks)
- Clear communication & stakeholder influence—able to collaborate across teams and drive decisions
- Project & business process management experience
- Comfort working in a dynamic, fast-paced environment
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Desirable Skills & Experience
✅ Reaction hazards expertise (lab experience in reaction data/kinetics for large-scale manufacturing) ✅ International project experience (preferably Singapore/US-based) ✅ Experience in problematic solving & Lean methodologies ✅ Process qualification/validation background ✅ Change management in regulated environments (COMAH facility exposure)
Why Join AstraZeneca?
A Culture of Impact
- Work on cutting-edge projects alongside top global scientific minds
- Modern facilities with curiosity, kindness, and ambition as core values
- Collective brilliance—combinations of diverse expertise spawn innovative solutions
- Digital & Lean methods applied to build sustainable, end-to-end processes
Purpose-Driven Work
- Shape the future of pharmaceutical manufacturing—delivering life-changing medicines
- Join a science-first company where prototyping and improvement are ingrained
- See your work directly impact patients worldwide
Office-First, Flex-Friendly Culture
- Requires minimum 3 days/week in-office for collaboration, innovation, and accountability
- Flexible but balanced—office presence aligns with operational needs while respecting individual circumstances
Inclusion & Commitment to Difference
💙 "Building an inclusive and equitable environment where everyone belongs."
- Equitable hiring practices—welcoming applicants from all backgrounds
- Reasonable accommodations for candidates during recruitment (please specify needs in applications)
- A dedication to innovation by leveraging diversity and empowering ambition
Join Us
If you’re ready to build and optimize processes that scale life-saving medicines, send your CV for Process Engineer (Macclesfield).
[Apply now]
📅 Date Posted: 02-Jul-2026 📅 Closing Date: 08-Jul-2026
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