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Commissioning & Qualification Lead Engineer

Commissioning & Qualification Lead Engineer

FinancecolombiaSonora, Mexico
Hace 23 días
Tipo de contrato
  • Teletrabajo
Descripción del trabajo

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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    Lead Engineer • Sonora, Mexico