Automation Engineer

<p><strong><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Automation (EBR/MES) Engineer &#8211; Kerry</span></strong></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">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. </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">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.</span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Responsibilities will include</span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <ul style="margin-top: 0cm"> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Collaborate with manufacturing, quality, IT, and validation teams to gather requirements and translate them into functional EBR designs.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Ensure EBRs comply with GMP, FDA 21 CFR Part 11, EU Annex 11, and other relevant regulations.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Participate in user acceptance testing (UAT), troubleshooting, and resolution of EBR-related issues.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Support validation activities, including authoring and executing test scripts and supporting documentation.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Drive continuous improvement of EBR templates and processes to enhance efficiency and data integrity.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Provide training and support to end-users on EBR functionality and best practices.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Maintain documentation for EBR design, configuration, and change management.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Design, develop, and configure EBRs within the MES platform (Apprentice Tempo).</span></li> </ul> <p style="margin-left: 18.0pt"><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p style="margin-left: 18.0pt"><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Required Qualifications</span></p> <p style="margin-left: 18.0pt"><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <ul style="margin-top: 0cm"> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Strong knowledge of GMP, data integrity, and regulatory requirements for electronic records.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Experience with at least one MES platform (e.g., Apprentice TEMPO, Werum PAS-X, Emerson Syncade, Siemens Opcenter).</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Proficient in process mapping, requirements gathering, and technical documentation.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Excellent analytical, problem-solving, and communication skills.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Preferred Qualifications</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Experience with batch process automation and integration with shop floor systems (PLC, SCADA, DCS).</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Familiarity with GAMP 5, validation lifecycle, and computerized system validation.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Ability to work in a global, cross-functional team environment.</span></li> <li><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Advanced knowledge of pharmaceutical manufacturing processes.</span></li> </ul> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">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. </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Arcadis is a leading Project Management and Engineering Company delivering Full-Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health &amp; Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time. </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif"> </span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Arcadis is an Equal Opportunities Employer.</span></p> <p><span style="font-size: 10.0pt;font-family: 'Verdana',sans-serif">Recruitment Agencies: Please do not reply to this job advert.</span></p>