We are seeking a highly skilled and experienced Lead Manufacturing Execution System (MES) Engineer to join our dynamic team supporting projects in the pharmaceutical industry. As a Lead MES Engineer, you will play a critical role in the successful implementation, optimization, and support of MES solutions across multiple manufacturing sites. You will collaborate closely with cross-functional teams, including operations, IT, automation, and quality, to ensure the seamless integration of MES systems with existing manufacturing processes. Your expertise will contribute to enhancing operational efficiency, regulatory compliance, and data integrity within our pharma manufacturing environment.
Responsibilities:
· Design and implement MES solutions in accordance with industry best practices, GxP regulations, and company standards.
· Collaborate with business stakeholders, operations teams, and subject matter experts to gather requirements and define system specifications for MES projects.
· Lead the configuration, customization, and integration of MES systems, ensuring alignment with business processes and manufacturing requirements.
· Provide technical expertise in areas such as electronic batch records, recipe management, data collection, equipment integration, and reporting.
· Develop and execute test protocols to validate MES functionality and ensure compliance with regulatory requirements.
· Support system lifecycle management activities, including system upgrades, patches, and migrations, while minimizing downtime and ensuring system availability.
· Troubleshoot and resolve complex issues related to MES functionality, data integrity, and system performance.
· Collaborate with cross-functional teams to identify opportunities for continuous improvement and implement enhancements to optimize manufacturing operations.
· Provide training and guidance to end-users on MES functionality, workflows, and best practices.
· Stay abreast of industry trends, regulatory changes, and technological advancements in the MES space, and apply this knowledge to drive innovation and efficiency.
Qualifications:
· Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
· Minimum of 10 years of experience in implementing and supporting MES solutions within the pharmaceutical or biotech industry.
· Strong understanding of GxP regulations, including 21 CFR Part 11, Annex 11, and GAMP5.
· Proficient in MES platforms such as Werum PAS-X, Rockwell ProPack Data, Siemens Camstar, or similar systems.
· Hands-on experience with MES configuration, customization, and integration, including electronic batch records, equipment interfaces, and reporting tools.
· Solid knowledge of manufacturing processes in the pharmaceutical industry, including batch manufacturing, packaging, quality control, and supply chain management.
· Familiarity with automation systems, SCADA, and PLC programming is a plus.
· Excellent problem-solving and troubleshooting skills, with the ability to analyze complex issues and provide effective solutions.
· Strong project management skills, with the ability to lead multiple projects simultaneously, prioritize tasks, and meet deadlines.
· Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders at all levels of the organization.
