Process & Manufacturing Engineering Lead

Project Role : Process & Manufacturing Engineering Lead

Project Role Description : Lead and plan manufacturing engineering programs. Lead teams of engineers who define processes to fabricate, assemble, inspect and test new products and machines based on production engineering and design principles. Define the supporting tools and fixtures needed for production. Ensure teams are developing product specifications and define the quality standards and inspection methods for manufacturing products and machines.

Must have skills : Manufacturing Operations

Good to have skills : NA

Minimum 12 Year(s) Of Experience Is Required

Educational Qualification : 15 years full time education

As a Technology Industry Architect, you will bridge complex Biopharma manufacturing domain knowledge with cutting-edge digital technology, translating operational and compliance challenges into scalable, future-ready solutions for clients. You will work with client leadership teams and Accenture's global technology ecosystem to architect and deliver transformative solutions across the Biopharma manufacturing and quality operations value chain.

Roles & Responsibilities:

Expected to be an SME, collaborate and manage the team to perform.

Responsible for team decisions.

Engage with multiple teams and contribute on key decisions.

Provide solutions to problems for their immediate team and across multiple teams.

Contribute to the design and shaping of digital transformation solutions for Biopharma or Biotech manufacturing operations, bringing domain context and regulatory understanding.

Support the development of solution blueprints covering OT/IT integration, manufacturing digitalisation platforms, and industrial AI grounded in GxP compliance requirements.

Engage in Digital Twin and simulation-based initiatives for bioprocess optimisation, yield improvement, and batch cycle time reduction.

Engage with CXO and senior client stakeholders to shape digital manufacturing and quality transformation roadmaps.

Professional & Technical Skills:

Must To Have Skills: Biopharma or Biotech manufacturing operations experience across biologics, cell & gene therapy, vaccines, biosimilars, or industrial biotech.

Knowledge of Manufacturing Execution Systems (MES) and GxP-compliant computerised systems validation (CSV) – IQ, OQ, PQ.

Familiarity with regulatory frameworks including 21 CFR Part 211/EU GMP Annex 1 & 2, 21 CFR Part 11/EU Annex 11, GAMP 5, and ICH Q7/Q10/Q11.

Experience with Industrial IoT, SCADA, DCS, Historian, and LIMS platforms in regulated manufacturing environments.

Exposure to Biopharma manufacturing platforms such as Veeva Vault, AVEVA, Siemens Opcenter, Syncade, or TrackWise.

Additional Information:

The candidate should have a minimum of 8 years of experience in Biopharma or Biotech manufacturing operations.

This position is based at our Bengaluru/Pune office.

A 15 years full time education is required.