Process & Manufacturing Engineering Lead

Overview

Lead and plan manufacturing engineering programs, leading teams of engineers who define processes to fabricate, assemble, inspect and test new products and machines. Serve as a Technology Industry Architect bridging Biopharma manufacturing domain knowledge with digital technology.

What you'll do

• Lead and plan manufacturing engineering programs and manage the team to perform as an SME, taking responsibility for team decisions.
• 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 quality standards and inspection methods for manufacturing products and machines.
• Engage with multiple teams and contribute to key decisions, providing solutions to problems for the immediate team and across 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.

What you'll need

• Minimum 12 years of experience (required).
• 15 years of full-time education.
• Manufacturing Operations (must have skill).
• 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.
• The candidate should have a minimum of 8 years of experience in Biopharma or Biotech manufacturing operations.

Details

• Based at the Bengaluru/Pune office.