PURPOSE OF JOB ROLE:
The Project Engineer will play a key role in clients digital transformation journey, focusing on the rollout and deployment of Mendix Next-Gen MES across UK and USA Clinical Manufacturing sites. The purpose of the role is to lead and support the adoption of the Mendix low-code platform within GMP-regulated environments, ensuring compliance, system validation, and business alignment. The successful candidate will bridge IT and Manufacturing, driving innovative solutions under the SAFe (Scaled Agile Framework) methodology while enabling operational excellence and regulatory compliance.
KEY RESPONSIBILITIES:
* Manage the deployment and rollout of Mendix Next-Gen MES across the Pharma clinical manufacturing sites.
* Spearhead the adoption of the Mendix low-code platform, delivering prioritized use cases that drive digital transformation across GMP operations.
* Lead and coordinate cross-functional agile teams to align business needs with IT capabilities.
* Ensure solutions comply with GxP, CFR Part 11, and GMP regulatory requirements, and that all MES systems are properly validated.
* Work closely with global and local site stakeholders (Manufacturing, Quality, IT, Engineering) to ensure seamless integration into existing processes.
* Support change management, training, and awareness sessions to accelerate adoption of Mendix Next-Gen MES across sites.
* Track, monitor, and report rollout progress, risks, and dependencies to ensure timely delivery of program KPIs.
QUALIFICATION REQUIREMENTS:
Minimum Level of Education:
* Bachelor’s degree (required)
* Master’s degree (preferred)
Area of Specialisation:
* Engineering, Computer Science, Information Systems, Automation, or related field
Why is this Level of Education Required?
* A strong technical and engineering foundation is essential to support MES implementation in GMP-regulated environments, interpret compliance requirements, and work with agile IT/manufacturing teams..
Minimum Level of Job-Related Experience, Knowledge, & Technical Skills Required
* 5+ years of experience in MES, Manufacturing IT, or Digital Transformation within GMP-regulated pharmaceutical/biotech manufacturing.
* Experience with MES systems (Opcenter, Werum PAS-X, or Mendix-based solutions preferred).
* Familiarity with GxP compliance, CFR Part 11, and system validation processes.
* Demonstrated experience in agile methodologies (SAFe preferred) and managing cross-functional teams.
* Strong ability to bridge IT and business, aligning technical capabilities with manufacturing operations.
* Proven track record in digital transformation projects within life sciences.
* Ability to work independently and as part of a multidisciplinary team.
Why is this Level of Experience Required?
The position requires a highly skilled professional able to operate independently in a regulated environment, ensuring that MES deployments meet business needs, compliance expectations, and audit readiness. Prior MES rollout and validation experience reduces risk and accelerates adoption
Other Job-Related Skills/Background
* Experience with low-code/no-code platforms (Mendix strongly preferred).
* Strong stakeholder management and communication skills.
* Proficiency in documentation lifecycle management in regulated environments.
* Knowledge of cloud deployment models and integration with IT/OT systems.