Commissioning & Qualification Lead Engineer

About Position

• Position:Commissioning & Qualification Lead Engineer
• Experience: 10+ years

Qualification: Any PG/UG

Location: Candidate will work for overseas location- Europe. Will work for our client.

Job description

• The C&Q Lead will be responsible for on-site C&Q Activities following ISPE/ASTM methodologies utilizing GDP, GEP & CGMP principles.
• They will lead a team of Validation/Verification, Commissioning Engineers/ subject matter experts to perform the commissioning/qualification of equipment, utility systems, facilities and automation systems for a number of blue chip pharmaceutical clients.
• We aim to expand our operations with the assistances of the C&Q lead. We are searching for a driven individual who has +10 Years industrial experience in a C&Q Lead/ Senior Validation/Engineering position with previous work experience in a GMP Environment & Large Scale Capital Project or Start-Up Projects in the Life Science Industry.

Other Skills and Abilities

• Detailed understanding of regulations/guide lines & industry practices for

C&Q/verification methodologies (ISPE/ASTM).

• Excellent written and verbal communication skills.
• Self-motivated and willing to take ownership and drive projects to completion.
• Excellent organization skills.
• Ability to handle multiple tasks accurately and prioritize effectively.
• Ability to work on own initiative or as part of a team.
• Demonstrates flexibility, attention to detail, an aptitude for analysis and an ability to apply standard problem solving tools for resolution.
• Interaction and teaming with cross functional teams (Internal/ External) and ability to lead in areas of conflict resolution.

Main Duties

C&Q Project lead main duties outlined below

• Liaise with Client as company representative.
• Planning, developing, execution, reporting of C&Q Deliverables.
• Liaison with the Design Lead (Architect Engineer), Project manager, other stakeholders to enable effective leveraging (where applicable) and timely Right First Time execution and compliance of Commissioning & Qualification deliverables.
• Provide Leadership in assigning work and providing resolution to a wide range of problems.
• Management of Contractors, scheduling, resources, budget.
• Trending of data, issuance of reports in a timely & accurate manner to support Project metrics.
• Review and Approval of Protocols, Reports and associated Deviations as applicable.
• Maintain Master plans & Inventory of systems.
• Generation, review and approval of C&Q strategies as applicable.
• Interfacing with Global/Local client representatives to ensure compliance.
• Represents the Validation Methodology and outputs at Compliance Quality / Regulatory Inspections.
• Conducts training as required.
• Generation of SOPs/ other documentation as applicable.
• Maintain change control system for projects.

Key Consideration

Previous experience Leading Projects in Pharmaceutical, Biopharmaceutical and or Medical Device Industries, covering (Clean and Black) utilities, facility clean rooms, process equipment & automation systems (C&Q Baseline guides / ASTM 2500E :SD&V/ GAMP 5) is essential to this role.

Any Graduates/PG

If interested please send your UPDATED Profile with below mentioned details.

Current CTC

Expected CTC

Notice Period

Reason for Job Change

With Regards,

Shruthi B - HR Recruiter

AARNA HR SOLUTIONS PVT LTD

Mob No: 9108013329;