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Job Title: MES Consultant

Location: USA / Remote

Employment Type: Contract

Job Description

Must Have Very strong experience in Syncade

The role requires:

• Relevant Pharma experience
• Possess a deep understanding and extensive experience in MES systems (preferably Syncade), data integration, networking, and proficiency in ERP systems (preferably SAP)
• Understanding of various client quality and manufacturing impacts involved with MES implementation.
• GxP systems implementation or software development life cycle as well as supporting project and validation methodologies (CSV).
• Experienced in operating withing a regulated environment, possessing understanding of GMP, 21 CRF part 11, and validation criteria.
• Proficiency in Syncade modules, including WF, OM, MM, ET and RA
• Solid understanding of integration methodologies between Syncade and other manufacturing systems (e.g. ERP, SCADA, PLCs)
• Familiar with the processes involved in biotech or pharmaceutical manufacturing, including operational workflow and EBR.
• MES recipe authoring or MBR development
• Electronic batch record (EBR) design or validation experience
• Experience leading people or complex projects
• Willingness to gain additional knowledge of the MOM platform and integration capabilities.
• Excellent analytical and problem-solving skills.
• Excellent written, verbal communication and presentation skills

Responsibilities (include but are not limited to):

• lead the design, implementation, and configuration of electronic batch records within Syncade MES solution, ensuring alignment with business objectives and manufacturing requirements.
• Collaborate with cross-functional teams, including process experts, production supervisors, and IT professionals, to gather requirements and translate them into functional specifications.
• Configure Syncade modules including WF, OM, MM, ET and RA
• Conduct thorough testing and validation of project solutions, including integration with other manufacturing sys such as ERP, SCADA and PLCs
• Collaborate with vendors, consultants, and stakeholders to troubleshoot and resolve technical issues ensuring minimal disruption of the production process.
• Participate in internal and external audits/inspections.
• Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
• Ability to provide training and technical guidance to engineers and end users.

Basic Qualifications:

• Bachelor's degree (engineering/ business informatics or equivalent exposure to the IT industry or business analysis)
• 10 years' experience in working with the manufacturing industry/shop-floor (functional or technical) preferably in life-science industry
• BS or BA in biochemical engineering, chemical engineering, biotechnology, chemistry, biology, or equivalent with at least 5 years of relevant experience or
• MA/MS in biochemical engineering, chemical engineering, biotechnology, chemistry, biology, or equivalent with at least 5 years of relevant experience.