Digital Manufacturing CSV / CSA - Experienced Associate

Industry/Sector

Not Applicable

Specialism

Operations

Management Level

Associate

Job Description & Summary

The Opportunity

Join our Acceleration Center India and help shape the future of business for our diverse client portfolio across geographies and jurisdictions. You’ll work at the heart of global teams across Advisory, Assurance, Tax and Business Services—solving real client challenges through connected collaboration. We’ll help you grow your skills so you can go further. With hands-on learning, cutting-edge tools and an inclusive culture, this is your opportunity to do inspiring work that makes a difference—every day.

As a Digital Manufacturing CSA/CSV - Experienced Associate, you will specialize in optimizing operational efficiency and effectiveness within our Operations Consulting practice. You will analyze client needs, develop operational strategies, and provide guidance to streamline processes, improve productivity, and drive business performance. As an Associate, you will focus on learning and contributing to client engagements and projects, developing your skills and knowledge to deliver quality work. You will be exposed to clients to learn how to build meaningful connections, manage and inspire others, and grow your personal brand by deepening your technical knowledge of firm services and technology resources.

In this role at PwC Acceleration Center India, you will work closely with clients to analyze product development lifecycles, identify bottlenecks, and develop strategies to enhance speed to market, reduce costs, and improve quality. You will provide guidance on implementing lean manufacturing principles, optimizing supply chain integration, and leveraging digital technologies. You are expected to anticipate the needs of your teams and clients, embrace ambiguity, ask questions, and use these challenges as opportunities for growth. This position offers a dynamic environment where adaptability and reliability are key to success.

Responsibilities

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

The Experienced / Senior Associate – 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.

• Quality & Regulatory Compliance

• 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.

• Client & Team Collaboration

• 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.

• Knowledge & Capability Building

• 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.

Skills Preferred:

• 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.

Educational Background:

• 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.
  What You Must Have
  
  - At least a Bachelor's degree
  - At least 2 years of experience
  - Oral and written proficiency in English required
  
  What Sets You Apart
  
  - Familiarity with shop floor operations and regulatory compliance
  - Experience with industry-leading MES tools like Tulip and Apriso
  - Understanding of basic supply chain concepts and logistics
  - Experience in planning and managing end-to-end implementations
  - Familiarity with IoT sensors and real-time manufacturing data analysis
  - Knowledge of enterprise tools like SAP and Oracle
  - Experience with Tulip platform configuration and data integration

Travel Requirements

Not Specified

Job Posting End Date