Senior AssociateDigital Manufacturing CSV-CSA

Industry / Sector

Not Applicable

Specialism

Operations

Management Level

Senior Associate

Job Description & Summary

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 - Senior Associate CSV / CSA (Pharmaceuticals & Life Sciences Advisory)

The 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

Client & Team Collaboration

Knowledge & Capability Building

Skills Preferred :

Educational Background :

Additional Information

Travel Requirements

Not Specified

Job Posting End Date

January 23 2026

Required Experience :

Senior IC

Key Skills

Lean Manufacturing,Six Sigma,Continuous Improvement,ISO 9001,Lean Six Sigma,Management Experience,Manufacturing & Controls,5S,Manufacturing Management,Kaizen,Chemistry,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1