Automation (EBR/MES) Engineer - Kerry The successful Automation / EBR Design Engineer is responsible for designing, configuring, and optimizing Electronic Batch Record (EBR) solutions within the Manufacturing Execution System (MES) to ensure compliant, efficient, and reliable batch documentation processes in pharmaceutical manufacturing.
Qualified with a Bachelor's Degree in Engineering, Computer Science, Life Sciences, or related field.
The successful Engineer will have 2+ years of experience in MES/EBR design or pharmaceutical manufacturing IT systems.
Responsibilities Collaborate with manufacturing, quality, IT, and validation teams to gather requirements and translate them into functional EBR designs.
Ensure EBRs comply with GMP, FDA 21 CFR Part 11, EU Annex 11, and other relevant regulations.
Participate in user acceptance testing (UAT), troubleshooting, and resolution of EBR-related issues.
Support validation activities, including authoring and executing test scripts and supporting documentation.
Drive continuous improvement of EBR templates and processes to enhance efficiency and data integrity.
Provide training and support to end-users on EBR functionality and best practices.
Maintain documentation for EBR design, configuration, and change management.
Design, develop, and configure EBRs within the MES platform (Apprentice Tempo).
Required Qualifications Strong knowledge of GMP, data integrity, and regulatory requirements for electronic records.
Experience with at least one MES platform (e.g., Apprentice TEMPO, Werum PAS-X, Emerson Syncade, Siemens Opcenter).
Proficient in process mapping, requirements gathering, and technical documentation.
Excellent analytical, problem-solving, and communication skills.
Preferred Qualifications Experience with batch process automation and integration with shop floor systems (PLC, SCADA, DCS).
Familiarity with GAMP 5, validation lifecycle, and computerized system validation.
Ability to work in a global, cross-functional team environment.
Advanced knowledge of pharmaceutical manufacturing processes.
This role is primarily based onsite at a pharmaceutical manufacturing facility, with occasional remote work as permitted.
The EBR Design Engineer will interact with production, quality, and IT teams in a highly regulated, collaborative environment.
Arcadis is an Equal Opportunities Employer.
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