Lead MES Validation Engineer 1734

About SimoTech

SimoTech 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 SimoTech

What is it like to work at SimoTech? 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 SimoTech 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.