Manufacturing Specialist

Job Title: Manufacturing Specialist

GCL D

Be part of history in the making. AstraZeneca is building its first biologics manufacturing campus in Singapore a groundbreaking USD 1.5 billion investment that will serve as a global hub for innovation and excellence.

This state-of-the-art facility will deliver end-to-end Antibody-Drug Conjugate (ADC) capabilities with different manufacturing units/buildings in one campus

• Small molecule- chemical API production
• Large molecule- monoclonal antibody manufacturing
• Conjugation
• Fill-and-finish operations including sterile filling and lyophilization
• Final secondary packaging

The campus will be equipped with modern digital and automation infrastructure enabling autonomous manufacturing powered by artificial addition it will be designed for carbon neutrality embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologics manufacturing.

We are looking for passionate individuals with relevant experience who thrive in dynamic environments and bring a make-it-happen attitude. Joining us means contributing to a project that will not only transform AstraZenecas global supply chain but also advance life-changing medicines for patients everywhere.

If youre ready to shape the future of biologics and be part of a once-in-a-generation project we want you on our team.

We are recruiting Manufacturing specialist for all the five different manufacturing units

Job Title: Manufacturing Specialist

Introduction to role

Are you passionate about transforming innovative manufacturing technologies into reliable medicines for patients As a Manufacturing Specialist you will play a key role in bringing our pioneering Singapore biological campus from project execution through qualification and into commercial operations. Working within one of our manufacturing areas API manufacturing mAb Drug Substance Conjugation Aseptic Filling or Secondary Packagingyou will provide technical expertise and shopfloor leadership to ensure safe compliant and efficient manufacturing. You will work closely with Engineering Quality MSAT Validation Supply Chain and EHS to support equipment start-up process optimization trouble-shooting and continuous improvement while building operational excellence from Day One.

• Equipment Ownership and Lifecycle: Serve as the technical owner for assigned manufacturing unit ensuring equipment is installed qualified and maintained in a state of readiness for GMP operations throughout its lifecycle.
• Start-up and Qualification Leadership: Plan and support FAT SAT commissioning qualification validation and handover activities; prepare review and implement protocols and technical - documentation to site standards and GMP requirements.
• Shopfloor Technical Support: Act as primary contact for equipment-related issues; provide rapid trouble-shooting performance monitoring and breakdown investigations to protect safety quality and schedule.
• Operational Readiness and GMP Execution: Drive SOP development batch record inputs equipment setup line readiness material flow reviews and operator training; ensure execution aligns with validated states and production plans.
• Digital and Data Integrity: Ensure alignment between DCS recipes and MES - master batch records and maintain complete compliant documentation that supports audit readiness and knowledge transfer.
• Safety Quality and Regulatory Oversight: Apply a safety-first mind-set; participate in risk assessments and hazard reviews; support deviations CAPAs change controls and corrective actions tied to equipment and operations.
• Cross - functional Collaboration: Coordinate with Manufacturing Maintenance QA Validation EHS PT&D Supply Chain and vendors to progress qualification readiness trouble-shooting and production support.
• New Product Introduction and OEE: Represent Manufacturing for introductions and campaigns; plan readiness for new systems and PPQs; find opportunities that improve reliability uptime and OEE.
• Single-Use Strategy and Availability: Lead lifecycle standardization and inventory management of single-use systems and consumables to enable seamless defect-free execution and supply continuity.
• Continuous Improvement and Reliability: Drive root cause analysis lessons learned and Lean problem solving; deliver improvements in cleaning setup changeover maintenance coordination automation and shopfloor simplification that elevate equipment reliability and right-first-time performance.

• Bachelors degree in Engineering Chemical Engineering Mechanical Engineering Pharmaceutical Engineering Biotechnology or a related subject area.
• At least 5 years of experience in pharma or biopharma GMP manufacturing with hands-on exposure to manufacturing equipment technical operations or production-support.
• Strong hands-on experience in equipment trouble-shooting fault diagnosis and issue resolution in a GMP manufacturing environment.
• Experience supporting equipment qualification and validation including exposure to FAT SAT IQ OQ and PQ activities.
• Good understanding of GMP documentation deviation management change control CAPA and equipment lifecycle management.
• Demonstrated dedication to protection quality and delivery in a regulated manufacturing environment.
• Strong written and verbal communication skills with good attention to detail.
• A strong safety-first mind-set with awareness of operator safety equipment safety containment control and shopfloor usability.
• Comfortable working in a start-up or evolving manufacturing environment.
• Strong multi-functional collaboration skills with the ability to work optimally across Production Engineering Validation QA and EHS.

• Experience supporting the start-up and operational readiness of a new manufacturing facility production line or equipment platform.
• Experience in ADC high containment high potency aseptic filling large molecule or other highly controlled manufacturing environments.
• Familiarity with containment technologies automated process equipment cleaning validation and equipment performance monitoring.
• Experience in manufacturing investigations technical transfer process validation equipment reliability improvement or production support projects.
• High resilience and the ability to work effectively through ambiguity change and evolving business needs.
• Familiarity with Singapore regulatory requirements and global GMP expectations.
• Experience with structured problem solving diagnosing underlying problems Lean Six Sigma or reliability improvement tools.
• Solid understanding of EU GMP Annex 01
• Willingness and ability to travel and spend short periods near vendor sites to support equipment qualification or project activities.

At AstraZeneca you wont just operate manufacturing processesyoull help build them. Joining our new Singapore ADC campus means being part of a once-in-a-career opportunity to establish one of the worlds most advanced manufacturing facilities from project start-up through commercial operations.

Youll work alongside experts in Manufacturing Engineering MSAT Quality and Digital to solve complex technical challenges introduce innovative technologies and continuously improve how we manufacture life-changing medicines. We invest in your growth through hands-on learning multi-functional collaboration empowering you to develop your expertise while making a meaningful difference to patients around the world.

Step into a role where your equipment expertise powers safe reliable supply for patients and accelerates your developmentclaim your seat at the shopfloor and help us build a world-class capability in Singapore today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.