Lead MES Engineer – PAS|X (Contract)
About the Role
We are looking for a Lead MES Engineer to act as the technical authority for PAS|X across our client’s manufacturing operations. You will own the technical direction, quality and long-term performance of the electronic batch record (EBR) lifecycle, lead a team of MES engineers, and serve as the senior point of escalation for Operations, Quality and IT.
This role is central to the successful adoption of PAS|X and to building a sustainable, in-house MES capability that will outlast the initial implementation.
Key responsibilities
Technical Leadership and Ownership
- Act as the PAS|X design authority, owning solution architecture, configuration standards and design decisions across the Packaging, Fill Finish and Biologics units.
- Set and enforce GMBR design, build and review standards so that EBRs are consistent, maintainable and right-first-time.
- Own the MES technical roadmap, prioritising enhancements, upgrades and site projects in line with business and compliance needs.
- Lead the technical design and governance of Level 2 integrations between PAS|X and automation, equipment, laboratory, DCS and enterprise systems, including SAP.
Team Leadership
- Lead, mentor and develop a team of MES engineers. Allocate work, review technical deliverables and build capability across the team.
- Define and run the MES support model, including incident management, escalation paths, on-call arrangements and service levels.
- Coach Operations and Quality super-users and lead the development of training and technical documentation.
Change and Compliance
- Lead MES changes and site projects through change control, from impact assessment and design through testing, validation and release.
- Own the technical approach to system testing, commissioning and validation, ensuring operational readiness for each go-live.
- Ensure all PAS|X changes, support activities and documentation meet GxP, data integrity, change control and validation requirements. Represent MES during regulatory inspections and internal audits.
Operational Excellence
- Serve as the senior escalation point for critical PAS|X issues, leading resolution to protect manufacturing continuity and product quality.
- Lead root-cause investigations, deviations and CAPAs related to MES, and drive the elimination of recurring system issues.
- Use system performance and support data to identify and lead improvements in usability, reliability, data quality and process efficiency.
- Partner with Operations, Quality, IT, Automation and site leadership to optimise MES-enabled workflows and align on priorities.
Required Experience and Qualifications
- At least five years of MES experience in pharmaceutical, biotechnology or other regulated manufacturing, including a minimum of four years hands-on with PAS|X.
- Proven experience leading PAS|X design, configuration, testing and support, including GMBR development across the full EBR lifecycle.
- Demonstrated technical leadership, whether as a team lead, design authority or lead engineer on a PAS|X implementation.
- Strong knowledge of Level 2 integration architecture and the interfaces used to connect MES with automation, equipment and enterprise systems.
- Track record of leading MES issue resolution in a live production environment.
- In-depth understanding of GxP, CSV/CSA, change control and data integrity expectations, with experience defending MES during audits or inspections.
- Ability to influence and align senior technical and non-technical stakeholders.
- Strong analytical and problem-solving skills, with the ability to lead structured investigations and communicate clear recommendations.
- Excellent written and verbal communication skills in English.
Desirable Experience
- Leading PAS|X implementation or deployment in Packaging, Fill Finish or Biologics operations, ideally through at least one full go-live and hypercare.
- Experience with PAS|X version upgrades, multi-site rollouts or global template deployments.
- Familiarity with manufacturing automation, SAP, DCS, PLC and plant-level systems.
- Experience managing vendors, integrators or contract engineering resources.
- Experience leading cross-functional or international project teams.
What We Offer
- Top-of-market hourly rate, hybrid in Dublin
- An initial 12-month contract, with the potential to extend, leading the PAS|X deployment.
- A senior, high-impact role at the intersection of technology, Operations and Quality, with real ownership of design decisions, standards and the MES roadmap.
- The chance to take a new PAS|X solution through go-live and hypercare across Packaging, Fill Finish and Biologics, and to shape how it is supported for the long term.
Our client is committed to creating an inclusive workplace where people with different backgrounds, experiences and perspectives can contribute and succeed. We welcome applications from all qualified candidates.