Commissioning & Qualification Lead Engineer

Aarna HR Solutions Pvt Ltd; México; Presencial; MXN 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

Aarna HR Solutions Pvt Ltd is seeking a Commissioning & Qualification Lead Engineer to manage commissioning and qualification activities for top pharmaceutical clients in Europe. The ideal candidate will have over 10 years of experience and a background in leading projects covering clean utilities, clean rooms, and automation systems.

The role requires excellent communication and leadership skills, alongside a proactive approach to project management. A graduate or post-graduate degree is required. This position offers an exciting opportunity to work on high-impact projects in the biopharmaceutical sector.

Formación

• Minimum 10 years of experience in pharmaceutical/bio-pharmaceutical projects.
• Familiarity with ISPE/ASTM methodologies and GDP, GEP & CGMP principles.
• Experience managing contractors and project budgets.

Responsabilidades

• Lead a team of engineers in commissioning and qualification activities.
• Liaise with clients and manage project deliverables.
• Coordinate with multiple stakeholders for timely execution.
• Review and approve project documentation and protocols.

Conocimientos

Regulatory understanding

Excellent communication skills

Project ownership

Multi-tasking and prioritization

Team collaboration

Problem-solving aptitude

Educación

Any graduate or post‑graduate

Descripción del empleo

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 global/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.

Qualifications

Any graduate or post‑graduate.