Werum PAS-X MES Service Delivery Manager/Offshore Lead

• Technical/Functional Skills

• Werum PAS-X

• Key Responsibilities

• Oversee the end-to-end MES service delivery lifecycle, including planning, implementation, operation, and continuous improvement.

• Develop and implement service delivery strategies and processes aligned with business objectives and regulatory compliance.

• Monitor and manage key performance indicators (KPIs) to measure service delivery effectiveness and compliance adherence.

• Ensure adherence to SLAs, SLOs, and regulatory requirements.

• Manage service requests, incidents, and problems while maintaining compliance.

• Coordinate with IT infrastructure, quality assurance, and regulatory affairs teams.

• Build and lead a high-performing MES service delivery team.

• Provide coaching, mentoring, and development opportunities for team members.

• Foster a culture of compliance, quality, and continuous improvement within the team

• Build strong relationships with the customers.

• Understand customer needs and requirements in the context of life sciences regulations.

• Manage customer expectations and resolve issues promptly while maintaining compliance.

• Proactively identify and address customer pain points and regulatory challenges.

• Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements for the new MBR

• Troubleshoot and defects resolution during validation of Master Batch Records

• Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch Records

• Experience Required

• Design and creation of complex MBR for Weighing & Dispensing, Manufacturing and Packaging processes

• Site specific requirement analysis for each of the above processes and convert them into Batch Records

• Validation of the created MBRs for site deployment

• Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR’s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data

• Designing and developing State Diagrams in MES

• Determining updates for Master Data, State Diagrams, Equipment management

• Experience on SAP-MES interface, L2 integrations, report development

• Knowledge of ISA95/S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing.

• Good Communication and Analytical skills

• Hands on Experience in Werum PAS-X Specification, Execution, Compliance & Performance Module

• Experience in Werum PAS-X - Configuration, Customization

• Experience on Werum PAS-X Installation, Upgrade, Development and Configuration.

• Knowledge of GxP, GAMP, 21 CFR Part 11

• Roles & Responsibilities

• Werum PAS-X Service Delivery Manager

• Offshore Lead

• Client Liasoning

• IT Skills

• Knowledge on SQL queries, C-Sharp, Java,

• User management and system profile creations.

• Generic Managerial Skills

• Proven experience in MES implementation and support within the life sciences industry.

• Deep understanding of MES functionalities and industry best practices.

• Strong knowledge of relevant regulations (e.g., FDA, EMA, GxP) and compliance requirements.

• Experience in IT service management frameworks (ITIL) is preferred.

• Excellent project management and organizational skills.

• Strong leadership and interpersonal skills.

• Ability to build and maintain relationships with stakeholders, including regulatory agencies.

• Strong problem-solving and analytical skills.

• Excellent communication and presentation skills.