Manufacturing Execution Systems Engineer

Responsible for overseeing and executing MES validation activities related to the gLIMS implementation. This role ensures that all validation deliverables are completed on time and in full compliance with global guidelines, regulatory requirements, and quality standards. The position supports requirements gathering, testing, integration, and implementation of Manufacturing Execution Systems (MES) in conjunction with gLIMS and operates with a moderate level of supervision and autonomy. Responsibilities

• Lead gLIMS-MES interface validation activities and ensure timely completion, review, and approval of validation deliverables and documentation.
• Collaborate with the Site Change Manager and Automation SME to update or replace impacted MES/LIMS SOPs and processes in alignment with global and local standards.
• Work closely with gLIMS/MES leads, system users, and process owners to develop and revise MES recipes supporting gLIMS interfacing.
• Configure production recipes using object libraries as required.
• Execute validation test scripts, including test design, execution, simulation, and documentation activities, under the guidance of the supervisor or Validation SME.
• Ensure all validation activities comply with regulatory, quality, and cGMP requirements.
• Support cross-functional teams during MES integration and implementation activities.
• Perform additional duties and project activities as assigned.

• Bachelor’s degree in a STEM field or Computer Science with relevant industry experience.
• 5 10 years of experience in Automation, Validation, Quality Control, Pharmaceutical, or Biotech environments.
• Should have hands on experience in systems integration role, connecting Syncade to other software tools like LabVantage LIMS (referred to as gLIMS) and or other systems.
• Hands-on experience with MES, LIMS, or comparable manufacturing and laboratory systems.
• Strong knowledge of Computerized System Validation (CSV) methodologies, validation templates, protocols, and SOPs.
• Familiarity with GMP/cGMP regulations, quality systems, and regulatory compliance requirements.
• Experience with deviations, change controls, CAPAs, OTNs, and TrackWise or similar quality management systems.
• Understanding of process, equipment, cleaning, and computer system validation activities.
• Proficiency with Microsoft Project, Word, Excel, and PowerPoint.
• Strong project management, planning, organization, communication, and cross-functional collaboration skills.
• Ability to manage multiple priorities and medium-to-large validation projects within established timelines.
• Experience supporting gLIMS implementations or MES/LIMS integration projects.
• Background in pharmaceutical manufacturing operations, quality systems, or automation projects.
• Experience reviewing and approving validation protocols, test scripts, and summary reports.
• Regulated pharmaceutical / biotechnology manufacturing environment
• Cross-functional collaboration with Automation, Quality, Manufacturing, Validation, and IT teams
• Combination of independent work and collaborative project execution

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy., TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.