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 general/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 2500E:SD&V;/GAMP 5) is essential.