Werum PAS-X MES / Subject Matter Expert

Job Title

Werum PAS-X SME Subject Matter Expert

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

1. Design and creation of complex MBR for Weighing & Dispensing, Manufacturing and Packaging processes
2. Site specific requirement analysis for each of the above processes and convert them into Batch Records
3. Validation of the created MBRs for site deployment
4. Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR's, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data
5. Designing and developing State Diagrams in MES
6. Determining updates for Master Data, State Diagrams, Equipment management
7. Experience on SAP-MES interface, L2 integrations, report development
8. Knowledge of ISA95/S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing.
9. Good Communication and Analytical skills
10. Hands on Experience in Werum PAS-X Specification, Execution, Compliance & Performance Module
11. Experience in Werum PAS-X - Configuration, Customization
12. Experience on Werum PAS-X Installation, Upgrade, Development and Configuration.
13. Knowledge of GxP, GAMP, 21 CFR Part 11

Roles & Responsibilities

1. Werum PAS-X Service Delivery Manager
2. Offshore Lead
3. Client Liasoning

IT Skills

1. Knowledge on SQL queries, C-Sharp, Java,
2. User management and system profile creations.

Generic Managerial Skills

1. Proven experience in MES implementation and support within the life sciences industry.
2. Deep understanding of MES functionalities and industry best practices.
3. Strong knowledge of relevant regulations (e.g., FDA, EMA, GxP) and compliance requirements.
4. Experience in IT service management frameworks (ITIL) is preferred.
5. Excellent project management and organizational skills.
6. Strong leadership and interpersonal skills.
7. Ability to build and maintain relationships with stakeholders, including regulatory agencies.
8. Strong problem-solving and analytical skills.
9. Excellent communication and presentation skills.