Senior Technical Services Specialist - Process Validation Technical Lead
This is what you will do:
The Senior Specialist Technical Services (Process Validation Technical Lead) has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Process Validation Technical Lead will provide processing expertise to support the technology transfer, validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Process Validation Technical Lead will be responsible for process validation activities across multiple products, ensuring alignment with internal standards and regulatory requirements during technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Alexion Technical Operations, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process performance qualification (PPQ). The position is accountable for timely completion of technical transfer and validation related milestones, with particular emphasis on new product introduction, PPQ, Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.
You will be responsible for:
Serve as the technical lead for process validation activities across multiple products and workstreams.
Act as a subject matter expert (SME) in process validation, ensuring alignment with internal standards and regulatory requirements, and support/defend validation approaches during regulatory inspections.
Provide technical leadership and guidance for development of validation strategies and overall product lifecycle management.
Ensure on time delivery of validation documentation, reports, and project milestones.
Support and help shape development strategies for both new and existing product transfers.
Author critical validation documents, including master validation plans, risk assessments, and validation protocols.
Develop and implement risk assessments to proactively identify and mitigate potential technical or compliance risks.
Support multiple parallel validation work fronts, enabling efficient execution of overlapping projects.
Support Continued Process Verification, CPV, strategy development for new products
Lead the implementation of a lean/digital process validation framework, supporting parallel ADMF tech transfers while optimizing resource usage and reducing workload and lead times for all validation‑related activities.
Additional Responsibilities:
To provide process expertise in one, or both of the following disciplines:
Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
Downstream to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
To identify and implement process improvements, e.g. yield, cycle time reduction
To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
Lead any key process changes using change control system.
Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
To author and review common technical document (CTD) sections and reports for regulatory agency submissions.
To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
You will need to have:
Minimum of 5 years’ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, downstream purification unit operations and process validation.
Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
Engage in continual improvement through assessment and use of new PAT technologies.
Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
Ability to drive for results independently and adapt to rapidly changing priorities.
Experience of leading process validation activities is advantageous.
Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to Alexion.
Technical writing competency.
Excellent organizational skills with strategic thinking and vision for the group.
Demonstrated ability to drive for results and lead innovation and change.
Self-driven, able to prioritize, and to orchestrate multiple activities at once.
Consistently demonstrate sound business judgment when making decisions.
Ability to deal with ambiguity and complexity and influence others across levels of the organization.
We would prefer for you to have:
B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
Experience of authoring CMC sections of regulatory submissions
Date Posted
06-Mar-2026Closing Date
19-Mar-2026Our 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.