Commissioning & Qualification Lead Engineer

Commissioning & Qualification Lead Engineer Full-time Greetings Aarna HR Solutions is Bangalore based Human Resource Recruitment Company providing services to Various IT, ITES and Non- IT companies across India. Aarna Solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel. We have openings for “Commissioning & Qualification Lead Engineer” position with a reputed Company located in Bangalore and have to work for client located in Europe. 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. 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 assistance 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 Excellent written and verbal communication skills. Self-motivated and willing to take ownership and drive projects to completion. 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: ; #J-18808-Ljbffr