Commissioning & Qualification Lead Engineer
Full‐time.
Location: Bangalore.
Client location: Europe.
About Position
Experience: 10+ years
Qualification: Any graduate or post‐graduate
Role: Lead engineer responsible for on‐site commissioning & qualification activities following ISPE/ASTM methodologies and using GDP, GEP & CGMP principles.
Key Responsibilities
Lead a team of Validation/Verification, Commissioning Engineers and subject‐matter experts to perform commissioning/qualification of equipment, utility systems, facilities and automation systems for blue‐chip pharmaceutical clients.
Liaise with the client as the company representative.
Plan, develop, execute and report on C&Q; deliverables.
Coordinate with Design Lead, Project Manager and other stakeholders to ensure timely and compliant execution.
Provide leadership in assigning work and resolving a wide range of problems.
Manage contractors, scheduling, resources and budget.
Trend data, issue reports and support project metrics.
Review and approve protocols, reports and associated deviations.
Maintain master plans and inventory of systems.
Generate, review and approve C&Q; strategies.
Interface with integral/local client representatives to ensure compliance.




Represent validation methodology and outputs at compliance quality and regulatory inspections.
Conduct training and generate SOPs or other documentation.
Maintain change control system for projects.
Required Skills & Abilities
Detailed understanding of regulations, guidelines & industry practices.
Excellent written and verbal communication skills.
Self‐motivated, willing to take ownership and drive projects to completion.
Ability to handle multiple tasks accurately and prioritize effectively.
Ability to work independently and as part of a team.
Shows flexibility, attention to detail, aptitude for analysis and ability to apply standard problem‐solving tools.
Interaction and teaming with cross‐functional teams and ability to lead conflict resolution.
Key Consideration
Prior experience leading projects in pharmaceutical, biopharmaceutical or medical device industries, covering clean/black utilities, facility clean rooms, process equipment & automation systems (C&Q; baseline guides / ASTM ****E:SD&V;/GAMP 5) is essential.
Qualifications
Any graduate or post‐graduate.
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