MES Engineer
Role Overview
An experienced
MES Engineer
is required to join an established Manufacturing Execution Systems (MES) team supporting
biotech manufacturing operations
at a regulated production site.
The role focuses on the
design, development, enhancement, and support of electronic batch records (EBRs)
and MES recipes within a
GMP environment
, with strong involvement in
system validation, testing, and documentation
. You will work closely with manufacturing, quality, automation, and IT stakeholders to support live operations and deliver system improvements.
Key Responsibilities
* Partner with business and manufacturing stakeholders to
gather and translate user requirements
into compliant MES solutions.
* Design and develop
new electronic batch records and work instructions
within the MES platform.
* Modify, enhance, and deploy changes to
existing live recipes
, ensuring minimal impact to manufacturing.
* Produce and review
design specifications
, configuration documents, and technical documentation aligned with GMP and CSV expectations.
* Develop, execute, and review
test scripts
(IQ/OQ/PQ or equivalent) to support system changes and new MES functionality.
* Support
computer system validation (CSV)
activities in line with regulatory requirements and site procedures.
* Utilise
Kneat
(or similar validation lifecycle management tools) to manage validation documentation, testing, and traceability.
* Provide
day-to-day MES support
, including troubleshooting and resolution of system and recipe-related issues.
* Participate in
design reviews and risk assessments
, ensuring traceability from requirements through to testing and release.
* Apply an
object-oriented development approach
to create reusable MES objects across multiple batch records.
* Coordinate and participate in
solution testing
, ensuring robust testing practices and documentation standards are followed.
* Support investigations and resolution of
production-impacting MES issues
.
* Identify and drive
continuous improvement opportunities
across MES delivery, validation, and support processes.
* Collaborate with IT, automation, and manufacturing teams to deliver solutions aligned with business and quality needs.
* Stay current with
emerging MES technologies, regulatory expectations, and industry best practices
.
Required Skills & Experience
* Strong experience with
object-oriented programming
, including
Visual Basic scripting
.
* Proven experience implementing and supporting
MES solutions in a GMP-regulated environment
.
* Demonstrated experience with
computer system validation (CSV)
, including requirements, design specifications, risk assessments, and testing.
* Hands-on experience developing and executing
test scripts
and supporting validated system releases.
* Experience using
Kneat
or similar electronic validation lifecycle management systems.
* Strong ability to troubleshoot and support
MES or comparable manufacturing systems
.
* Experience working within a development team, with the ability to
take ownership of issues and solution delivery
.
* Direct experience engaging with end users for
requirements gathering and translation into technical solutions
.
* Good working knowledge of
automation systems
,
historians
, and
DCS platforms
.
* Solid understanding of
GMPs, regulatory requirements, and data integrity principles
.
* Excellent written and verbal communication skills for both
technical and non-technical stakeholders
.
* Demonstrated learning agility across both
technical systems and manufacturing processes
.
* Proactive mindset with the ability to identify issues, implement solutions, or escalate appropriately.
Nice to Have
* Experience supporting
biotech or pharmaceutical manufacturing environments
* Exposure to
PAS-X, Syncade, or similar MES platforms
* Experience working in
live manufacturing environments with frequent system changes