Commissioning & Qualification Lead Engineer

Aarna HR Solutions Pvt Ltd; Bengaluru; Remote; MXN 1,662,000 - 2,770,000; Full time

Job summary

Aarna HR Solutions Pvt Ltd is seeking a Commissioning & Qualification Lead Engineer for a Bangalore-based recruitment assignment with responsibilities to work on overseas client projects in Europe. The candidate should have 10+ years of experience and a background in GMP environments and capital projects in life sciences.

The role involves leading C&Q activities, coordinating cross-functional teams, and ensuring compliance with ISPE/ASTM methodologies while delivering quality outcomes for

Qualifications

• Experience in C&Q activities and leading validation teams.
• Understanding of GMP/CGMP principles and industry guidelines.

Responsibilities

• Lead on-site C&Q activities following ISPE/ASTM methodologies.
• Manage a team of Validation/Verification and Commissioning Engineers.
• Coordinate with client and internal teams to deliver C&Q deliverables on time.

Job description

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 CompanyLocated in Bangaloreand have to work for client located in Europe.

About Position:

Position: Commissioning & Qualification Lead Engineer

Experience: 10+ years

Qualification: Any Graduates/PG

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 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.

Qualification: Any Graduates/PG