We are currently looking for a Manufacturing Process Engineer and this role will involve the following:
Role Summary
We are seeking an experienced Manufacturing Process Engineer Supervisor with at least 5+ years of experience in Manufacturing Execution Systems (MES) and Operational Technology (OT) within a manufacturing environment. This role will support the implementation of a MES at the Cootehill site across all manufacturing processes, including required OT interfaces. The deployment will be closely aligned with Electronic Batch Record (EBR) initiatives. The ideal candidate will have hands‑on experience with new system implementations, PLC/SCADA, process and equipment automation, PCS/BMS systems, and a strong understanding of GxP requirements.
Main Responsibilities
Manufacturing Execution System / Automation Strategy
Support the development and implementation of a MES, ensuring alignment with equipment interfaces, ERP dependencies, and site automation needs.
Apply OT and automation standards to deliver standardised solutions and optimise manufacturing efficiency.
OT Project Governance
Ensure internal and vendor-delivered OT/automation design work meets site strategy, standards, and compliance requirements.
Lead technical design reviews and support testing, delivery, and validation activities.
Automation Engineering
Own the design, integration, and hands‑on technical execution of the MES.
Develop and optimise automated processes throughout design, testing, and implementation phases.
Contribute to validation documentation and quality compliance requirements.
Education & Experience
Bachelor’s degree in Electrical Engineering, Automation Engineering, Control Engineering, Mechatronics, or a related field.
Additional training or certifications in PLC/SCADA systems or OT cybersecurity (e.g., IEC 62443, GICSP) are advantageous.
5+ years’ experience in a technology role within an operations or manufacturing environment.
Experience with MES and automation systems in a cGMP‑regulated environment.
Proven track record in delivering and managing MES solutions.
Knowledge of FDA cGxP, 21 CFR Part 11, and software system validation.
Hands‑on experience with Siemens PLCs, SCADA systems, and AVEVA (OSIsoft) PI Data Historians.
Experience managing external automation/OT vendors and integrators.
Proficiency with SharePoint, Power BI, and digital collaboration tools.
Understanding GRC/information security principles is an advantage.
ERP and MES plant design and rollout experience desirable.
Abilities & Soft Skills
Strong verbal and written communication skills, with the ability to simplify complex technical topics.
Ability to influence, collaborate, and support digital transformation initiatives.
Hands‑on approach, comfortable working directly with equipment and manufacturing systems.
Strong problem‑solving, troubleshooting, and project management skills.
Highly organised with a strong digital mindset.
Familiarity with structured continuous improvement and project management methodologies.
Ability to work independently and collaboratively, with a proactive and adaptable mindset.
Commitment to maintaining validated systems, documentation integrity, and audit readiness.
Ability to contribute to cross‑functional digital initiatives and improve data visibility.
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