We are seeking a Senior Technical Product Owner with deep expertise in Manufacturing Execution Systems (MES) and Computerized System Validation (CSV/CSA) for a leadership role driving digital transformation across pharmaceutical manufacturing operations. The ideal candidate brings a proven track record of end-to-end MES implementations, global regulatory compliance, and cross-functional team leadership across multiple manufacturing sites.
This role sits at the intersection of Product Offering and Technology — championing compliant, scalable, and innovative MES solutions that support shop-floor excellence, data integrity, and inspection readiness.
Required Qualification & Experience EducationM.Tech / BTech/ B.Pharm / B.Sc in Pharmaceutical Sciences, Chemical Engineering, or related technical discipline.Experience15–20+ years of progressive experience in Life Sciences manufacturing IT, quality systems, or related domains.Demonstrated experience at leading pharma companies in Manufacturing or Quality10+ years experience in MES Project execution and delivery at leading Pharma companies Technical Expertise Deep expertise in MES platforms such as Werum PAS-X, Rockwell Pharma Suite, Honeywell TWM, or equivalent.: MES PlatformsERP, LIMS, QMS, DMS, LES, LMS, CDS, SAP HANA, SCADA/DAS/PLC, eCTD, RPA, ZOHO Vault, Argus, LSRIMS.: Systems GxP, GAMP 5, 21 CFR Part 11, Annex 11, EU GMP, USFDA, MHRA, TGA, WHO.: Regulatory FrameworksPERT, Critical Path Analysis, IFAS/EFAS/SFAS, Lean Six Sigma (Black Belt preferred).: Project Management Power BI, Tableau, Visio, MS Project.: Analytics Certifications (Preferred)Lean Six Sigma Black Belt Product Management certification GxP Audit CertificationGAMP 5 Practitioner or equivalent CSV/CSA certification Behavioral Competencies Strategic Thinking – Ability to translate manufacturing challenges into scalable digital solutions.Leadership & Influence – Proven ability to lead large, cross-functional, globally dispersed teams.Customer Centricity – Deep understanding of pharma customer implementation journeys and pain points.Analytical Rigor – Data-driven decision-making with strong risk assessment capabilities.Communication – Strong executive-level communication and stakeholder management skills.Continuous Improvement – Demonstrated culture of Kaizen, Lean thinking, and operational excellence.
Key Responsibilities:Product Ownership & Strategy Own the MES product roadmap, prioritizing features aligned to GxP compliance, business value, and operational efficiency.Define product vision for composable or modular MES architectures, supporting digital factory initiatives.Partner with solution consulting, sales, and customer success teams to drive product adoption and ARR growth.Lead Voice of Customer (VoC) exercises to incorporate manufacturing site requirements into the product backlog.MES Implementation & Technical Leadership Lead end-to-end Product Requirements for MES— from requirements to Product Release Define Solution architecture, integration parameters (ERP/SAP, LIMS, QMS, DMS, LES, CDS), data flows, and interface specifications.Govern computerized system validation (CSV) and computer software assurance (CSA) activities per GAMP 5, 21 CFR Part 11, Annex 11, and EU GMP requirements.Manage batch record, electronic logbook, scheduling, sampling, and shopfloor execution modules within MES.Support PLC/SCADA/DAS integration and resolve technical challenges in manufacturing environments.Regulatory Compliance & Data Integrity Ensure MES deployments are audit-ready for USFDA, MHRA, TGA, WHO, and other global regulatory bodies.Champion data integrity principles (ALCOA+) across all computerized systems.Lead system audit assessments, compliance gap analysis, and remediation planning.Author and review GxP documentation including URS, FS, DS, IQ/OQ/PQ protocols, and SOP/PQR documentation.Project & Stakeholder Management Identify and map all relevant stakeholders across engineering, business, sales, customers, and regulatory/compliance teams Build and maintain strong working relationships with cross-functional partners including R&D, QA, implementation, and commercial teams Collaborate with regulatory, quality, and compliance teams to ensure product requirements align with applicable standards (e.g., FDA 21 CFR Part 11, EU MDR/GMP)Engage with auditors, notified bodies, or customer validation teams during product qualification activities Serve as the primary point of contact between technical teams and business stakeholders Present product strategy, business cases, and investment decisions to senior leadership and executive sponsors Innovation Continuously scan the market, competitive landscape, and emerging technologies to identify innovation opportunities relevant to the product domain Champion a product vision that goes beyond incremental improvements — anticipating future customer needs rather than just responding to current ones Maintain and prioritize an innovation backlog distinct from the operational feature backlog Establish co-innovation partnerships with key customers to jointly define and validate new product capabilities.Evaluate and advocate for adoption of emerging technologies (AI/ML, cloud-native architectures, IoT, digital twins, etc.) where they create measurable product value