Lead MES Validation Engineer 1734
Posted 22 days 16 hours ago by SimoTechnology
SimoTech provides manufacturing automation andIT systems engineering, project management and validation services. We partnerwith life sciences companies to design, build, operate and optimise criticalprocess automation systems that deliver fast track project delivery,operational efficiency, improve manufacturing agility and achieve regulatorycompliance.
What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients' life-changing supplyofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.
We have an excellent opportunityfor a senior validation professional to take on a Lead MES Validation Engineerrole supporting a major pharmaceutical manufacturing facility in Co. Cork.
In this position, you will shapeand own the validation strategy for a new approach to combining automation and ManufacturingExecution System (MES). You will be providing technical leadership and guidingvalidation resources through successful delivery and execution. The role offersan opportunity to define best practices in system validation, supporttechnology integration for a new product introduction, and ensure fullcompliance with GxP standards throughout project deployment.
This is a key leadership role for acandidate who thrives on accountability, collaboration, and deliveringexcellence in an environment that blends innovation, quality, and digitaltransformation.
KeyResponsibilities- Develop and implement the overall validation strategy for the newmanufacturing approach, ensuring alignment with corporate and site goals.
- Lead the validation of key systems and supporting infrastructure,including integration with automation and data platforms.
- Influence stakeholders and drive for consensus to get the strategyapproved.
- Push for completion of deliverables to support the wider programmeneeds.
- Provide technical direction, mentorship, and oversight to validationengineers and contractors involved in the project.
- Coordinate validation planning, resource scheduling, and test executionto meet defined timelines and quality standards.
- Author and review validation documentation as required e.g. URS, DS, CS,IQ, OQ, PQ, and compliance reports.
- Ensure adherence to GxP regulatory requirements across all validationactivities.
- Maintain productive stakeholder relationships with Project Management,QA, IT, and Engineering teams to enable seamless delivery.
- Identify continuous improvement opportunities for validation processesand standards.
- Bachelor'sdegree in Engineering, Computer Science, Life Sciences, or a related discipline(or equivalent experience).
- Proven experience delivering MES validation or other complex systemvalidations within a pharmaceutical or regulated GMP environment.
- Strong understanding of validation lifecycle principles, computerisedsystem validation (CSV), and data integrity compliance.
- Deep familiarity with GAMP 5 guidelines and current EU/FDA validationexpectations.
- Proactive, detail-oriented approach with strong organisational andleadership capability.
- Experience with Emerson Syncade or other MES platforms.
- Experience with Emerson DeltaV an advantage.
- Prior experience supporting validation in small molecule or API manufacturing environments.
- Knowledge of automation system validation and system integration (DCS,historian, or batch management systems).
- Demonstrated ability to lead and manage validation activities acrossmultiple concurrent workstreams.
- Excellent communication and stakeholder engagement skills with theability to influence technical and non-technical audiences.
- Role provides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
- Develop new skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capitalprojects.