MES Platform Engineer 1686

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 in our clients’ life-changing supply of
products to patients. In return, there is excellent salary, benefits, career
progression, educational support and much more.  

MES Platform Engineer 1686

SimoTech has an exciting opportunity for an
experienced MES Platform Engineer to join our team, supporting a leading global
pharmaceutical organisation. This is a hybrid role where you will play a key
part in maintaining and evolving a critical MES landscape within a
high-performing manufacturing environment.

This position is suited to an engineer who
enjoys a balance of technical ownership and project delivery, with
responsibility for system validation, platform oversight, and the rollout of
MES capabilities including new environments and EBRs. You will work within a
collaborative, cross-functional team while also having the autonomy to take
initiative and drive activities forward.

Key
Responsibilities

• Take responsibility
  for server installations and system related activities including admin config
  settings, security, and access permissions.
  
• Collaborate
  with local and global IT, Quality, and external service providers to ensure
  successful software installation and configuration.
  
• Manage
  the Computer System Validation lifecycle for MES projects, from requirements
  definition through to business release.
  
• Generate CSV
  documentation in line with site procedures, GMP guidelines, and data integrity
  standards.
  
• Execute
  and review test scripts, analyse results, and ensure compliance with pre-defined
  acceptance criteria.
  
• Initiate
  and implement Change Control activities in accordance with Quality Standards
  and Practices.
  
• Determine
  solutions and provide recommendations for changes and improvements.
  
• Prioritise
  validation activities in line with the project schedule.
  
• Ensure
  adherence to all Environmental, Health and Safety requirements and contribute
  to incident investigations where required.
  

Requirements

Key Requirements

• Bachelors
  degree in Engineering, Computer Science, or related
  field with 5+ years’ experience in IT systems
  implementation, integration, computer systems validation, and support within a
  regulated environment.
  
• Strong
  hands-on experience with MES platforms, preferably Emerson Syncade, including
  system configuration.
  
• Proven
  experience across the full validation lifecycle, including requirements
  gathering, design documentation, testing, and troubleshooting.
  
• Solid
  understanding of 21 CFR Part 11, electronic records and signatures, and data
  integrity guidelines.
  
• Experience
  using validation and testing tools such as Kneat and ALM.
  
• Working
  knowledge of server, workstation, and Windows-based environments.
  
• Experience
  in EBR testing and MES deployment activities preferred.
  
• Strong
  communication and interpersonal skills, with the ability to engage effectively
  across technical and business teams.
  

Benefits