WERUM PAS_X- SN_Service Delivery Manager

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.