Validation Lead - Werum PAS-X MES

About the Role

USDM Life Sciences is hiring a senior Validation Lead with 10+ years of experience validating Werum PAS-X Manufacturing Execution Systems (MES) in GxP-regulated pharmaceutical or biotech manufacturing environments. The ideal candidate will have deep expertise in computer system validation (CSV) lifecycle management, electronic batch record (eBR) implementation, and PAS-X system configuration, and will serve as the primary validation authority for Werum PAS-X projects. This role requires a highly organized, inspection-ready professional capable of leading cross-functional validation workstreams from requirements through go-live.

Primary Responsibilities

• Serve as Validation Lead and subject matter expert (SME) for Werum PAS-X MES validation activities across manufacturing and quality operations.
• Author, review, and approve the full suite of validation lifecycle documentation including Validation Master Plans (VMP), User Requirements Specifications (URS), Functional Design Specifications (FDS), Configuration Specifications (CS), Traceability Matrices, and IQ, OQ, and PQ protocols and reports.
• Lead and coordinate the execution of IQ, OQ, and PQ validation testing activities, managing testers, resolving deviations, and ensuring timely, complete, and audit-ready documentation.
• Partner with Werum (Körber) and IT, quality, manufacturing, and regulatory affairs teams to ensure PAS-X configurations meet GxP requirements and site-specific business needs.
• Oversee the validation of PAS-X electronic batch records (eBR), process orders, material management, genealogy, and reporting functionalities.
• Manage validation activities for PAS-X system integrations with SAP ERP, DeltaV DCS, LIMS, and other enterprise systems.
• Lead and support 21 CFR Part 11 compliance assessments including audit trail reviews, electronic signature configurations, access control validation, and data integrity evaluations.
• Author and manage change control records, periodic reviews, and revalidation activities for PAS-X system changes, upgrades, and patches in accordance with GAMP 5 and site procedures.
• Develop and maintain Requirements Traceability Matrices (RTM) linking business requirements to design specifications, test scripts, and test evidence.
• Identify, document, and drive resolution of deviations and discrepancies identified during validation testing; author deviation reports and corrective action plans.
• Prepare and maintain PAS-X system inventory, risk assessments, and validation status reporting for internal and external stakeholders.
• Support FDA, EMA, and other regulatory agency inspections by preparing inspection-ready validation packages and serving as the validation SME during audit walkthroughs.
• Review and approve vendor-supplied documentation including Werum qualification deliverables, ensuring alignment with site validation standards.
• Provide validation strategy guidance and mentoring to junior validation engineers and cross-functional team members involved in MES delivery.
• Contribute to the development and continuous improvement of site validation procedures, templates, and standards.

Required Qualifications

• Minimum of 10 years of experience in computer system validation (CSV) within GxP-regulated pharmaceutical, biotech, or medical device manufacturing environments.
• Demonstrated hands-on experience validating Werum PAS-X MES, including electronic batch records (eBR), process order management, material management, and genealogy modules.
• Deep working knowledge of GxP regulatory requirements applicable to MES validation, including 21 CFR Parts 11 and 211, GAMP 5, EU GMP Annex 11, and ICH Q10.
• Extensive experience authoring and executing IQ, OQ, and PQ protocols, validation plans, traceability matrices, and summary reports to GxP standards.
• Experience managing PAS-X integration validation with upstream and downstream systems including SAP, DCS/SCADA, and LIMS platforms.
• Strong understanding of risk-based validation approaches, including system criticality assessments, risk assessments, and risk-based testing strategies.
• Demonstrated experience leading cross-functional validation teams across engineering, IT, quality, and manufacturing stakeholders.
• Experience supporting regulatory inspections and preparing audit-ready validation documentation packages.
• Proficiency with electronic document management systems (EDMS) and quality management systems (QMS) for validation lifecycle management.
• Strong written communication skills with the ability to produce clear, concise, and compliant validation documentation.
• Ability to manage multiple concurrent validation workstreams, prioritize effectively, and meet project deadlines in a dynamic manufacturing environment.

Preferred Qualifications

• Direct experience implementing or validating Werum PAS-X at a large biotech, biologics, or pharmaceutical company.
• Experience validating PAS-X in biologics, cell therapy, gene therapy, or sterile fill-finish manufacturing environments.
• Familiarity with Werum PAS-X version upgrades, patch qualification, and system lifecycle management activities.
• Experience with data migration validation, including data integrity assessments and data mapping for MES transitions or legacy system decommissioning.
• Knowledge of S88 batch process standards and how they are implemented within PAS-X batch orchestration and eBR design.
• Experience with manufacturing process deviations, investigations, and CAPA management processes in a regulated environment.
• Familiarity with ISA-95 enterprise-control system integration standards and MES/ERP/DCS integration architecture.
• ISPE GAMP 5 training or certification, or equivalent formal training in regulated SDLC and CSV practices.

Education & Certifications

Bachelor's degree in Life Sciences, Pharmacy, Biochemistry, Chemical Engineering, Information Systems, or a closely related field required.

Pay

• Hourly Rate Range (W2): USD 85.00 – 100.00
• Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
• Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.
• Full and part-time employees may be eligible for paid time off.
• All employees are eligible for USDM's rewards and recognition program.