Exprienced Associate_Digital Manufacturing - CSV-CSA

At PwC, our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. In product development and manufacturing at PwC, you will specialise in improving product development and manufacturing processes. You will work closely with clients to analyse product development lifecycles, identify bottlenecks, and develop strategies to enhance speed to market, reduce costs, and improve quality. Working in this area, you will also provide guidance on implementing lean manufacturing principles, optimising supply chain integration, and leveraging digital technologies.

Job Overview

PwC US ADVISORY - Experienced CSV/CSA (Pharmaceuticals & Life Sciences Advisory)

The Experienced– CSV/CSA will support delivery of global consulting engagements in Computer System Validation (CSV) and Computer Software Assurance (CSA) across the Pharmaceuticals, Life Sciences, and Medical Devices sectors.

The role involves hands-on execution of validation deliverables, supporting client workshops, and managing defined workstreams within larger validation programs. The candidate will work closely with project leads and managers to ensure quality, compliance, and on-time delivery of outcomes.

Position Requirements -

Validation Delivery & Execution

• Execute and review CSV/CSA deliverables including Validation Plans, User Requirements (URS), Functional and Design Specifications, Risk Assessments, Test Scripts (IQ/OQ/PQ, SIT/UAT), Traceability Matrices, and Validation Summary Reports.
• Apply risk-based validation and CSA principles to optimize effort while maintaining compliance with GAMP 5, 21 CFR Part 11, and Annex 11.
• Support end-to-end validation for ERP, MES, LIMS, eQMS, and data integrity systems, ensuring adherence to GxP and data integrity standards.
• Identify gaps in client processes and propose remediation or improvement actions aligned with regulatory expectations.
• Identify gaps in client processes and propose remediation or improvement actions aligned with regulatory expectations.
  
  

• Ensure all validation documentation meets regulatory and client-specific quality standards.
• Support inspection readiness, audit preparation, and CAPA/deviation closure activities.
• Maintain strong grounding in GxP Quality Management Systems (QMS), Digital Quality Systems (eQMS), and Computer System Assurance frameworks.
• Participate in quality risk assessments, deviation management, and CAPA reviews to support compliance and continuous improvement.
  
  

• Work collaboratively with cross-functional client and PwC teams (Quality, IT, Regulatory) during project execution.
• Support client workshops and meetings to gather requirements, review deliverables, and present progress updates.
• Review work products of junior associates, ensuring completeness, consistency, and adherence to PwC quality standards.
• Operate in both project-based and managed service environments, supporting ongoing validation and periodic reviews.
  
  

• Participate in internal initiatives, templates, and accelerators for validation documentation and CSA adoption.
• Contribute to team training, peer review sessions, and development of reusable playbooks.
• Stay updated on evolving FDA and EMA guidance related to CSV, CSA, and digital quality transformation.
  
  

• Technical / Domain
• Strong grounding in GxP Quality Systems, Computer System Validation (CSV), Computer Software Assurance (CSA), and Digital Quality Systems (eQMS).
• Hands-on experience in risk assessments, CAPA, deviation management, validation testing, and quality remediation.
• Knowledge of cGMP, GxP, FDA 21 CFR Part 11, and Process Validation (IQ/OQ/PQ).
• Familiarity with Operational and Scientific Excellence (OSE), yield improvement, and maintenance/reliability programs.
• Experience implementing or validating Veeva, Sparta, or similar eQMS platforms, or pharma shop-floor systems (e.g., MES, LIMS, ERP).
• Consulting / Delivery
• 3–6 years of relevant experience in Pharmaceuticals, Life Sciences, or Medical Devices domains.
• Experience in executing or supporting 1–2 full lifecycle CSV/CSA implementations (preferably also operated in a managed service environment).
• Strong documentation and technical writing skills with a focus on accuracy, traceability, and audit readiness.
• Ability to manage assigned workstreams, coordinate with cross-functional teams, and meet delivery milestones.
• Effective verbal and written communication with clients and internal stakeholders.
  
  

• MBA (Tier-2 or above) with relevant CSV/CSA background OR B.Tech. / M.Tech. / Life Sciences degree with strong experience in validation and regulatory compliance.
  
  

• Travel Requirements: Travel to client locations may be required as per project requirements.
• Line of Service: Advisory
• Specialism: Physical Product Development & Manufacturing – CSV/CSA
• Designation: Exp. Associate / Senior Associate
• Location: Bangalore, India
• Past Experience: Associate (2-4 years) of prior relevant work experience
• Preferred Work Experience: Validation/ Testing experience in Pharmaceutical & Life Sciences (PLS, including Medical Devices and Health Industry Advisory) preferred