Lead MES Validation Engineer 1734

About Simo. Tech Simo. Tech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

Why Simo. Tech What is it like to work at Simo. Tech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.

Lead MES Validation Engineer 1734 We have an excellent opportunity for a senior validation professional to take on a Lead MES Validation Engineer role supporting a major pharmaceutical manufacturing facility in Co. Cork. In this position, you will shape and own the validation strategy for a new approach to combining automation and Manufacturing Execution System (MES).

You will be providing technical leadership and guiding validation resources through successful delivery and execution. The role offers an opportunity to define best practices in system validation, support technology integration for a new product introduction, and ensure full compliance with GxP standards throughout project deployment.

This is a key leadership role for a candidate who thrives on accountability, collaboration, and delivering excellence in an environment that blends innovation, quality, and digital transformation.

Key Responsibilities

Develop and implement the overall validation strategy for the new manufacturing 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 strategy approved.

Push for completion of deliverables to support the wider programme needs. Provide technical direction, mentorship, and oversight to validation engineers and contractors involved in the project. Coordinate validation planning, resource scheduling, and test execution to 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 validation activities. Maintain productive stakeholder relationships with Project Management, QA, IT, and Engineering teams to enable seamless delivery. Identify continuous improvement opportunities for validation processes and standards.

Requirements

Key Requirements Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline (or equivalent experience). Proven experience delivering MES validation or other complex system validations within a pharmaceutical or regulated GMP environment. Strong understanding of validation lifecycle principles, computerised system validation (CSV), and data integrity compliance.

Deep familiarity with GAMP 5 guidelines and current EU/FDA validation expectations. Proactive, detail-oriented approach with strong organisational and leadership 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 across multiple concurrent workstreams. Excellent communication and stakeholder engagement skills with the ability to influence technical and non-technical audiences.

Benefits

What Simo. Tech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment. Opportunity to work with large corporate clients on exciting capital projects.