Commissioning & Qualification Lead Engineer
Full-time
Company & Opportunity
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.
Position Details
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.
Responsibilities
- 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
- 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: 9108013329;
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