Posted 2mo ago

Engineer - CQV

@ IPS - Integrated Project Services
New Delhi, Delhi, India
OnsiteFull Time
Responsibilities:write protocols, witness FATs, site walkdown
Requirements Summary:Bachelor of Science in Engineering; 0-2 yrs (Engineer I), 2+ yrs (Engineer II), 5+ yrs (Engineer III); experience in Pharmaceutical/Biotech/Medical Device; GMP utilities, equipment, systems; writing/exec of PFC/IQ/OQ/PQ forms; CQV/validation knowledge.
Technical Tools Mentioned:GMP, IQ, OQ, PQ, FAT, SAT, P&IDs, SOPs, QA
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Job Description
Job Description:

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer to join our dedicated team at our office located in Naraina Vihar, New Delhi.

 

Position Responsibilities 

  • Write C/Q/V documents following established standards and templates, including but not limited to the following:
    • Commissioning Forms
    • C/Q/V Protocols and Summary Reports
    • Standard Operating Procedures
    • Impact Assessments
    • Specifications (URS/FRS/DDS)
    • FATS/SATs
  • Perform field/site activities, including, but not limited to, the following:
    • Attend and witness FATs and SATs as a representative of IPS clients.
    • Execution of commissioning forms and witnessing of vendor start-up and testing.
    • Execution of C/Q/V protocols.
    • Walkdown and verification of system drawings (P&IDs, as-builts, etc.).
    • Compile data and prepare reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
    • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
    • Work with the Project Delivery department or CM for start-up and vendor testing.
    • Witness and troubleshoot as required.
  • Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
  • Read, understand, and utilize the IPS Best Practices and SOPs for delivery of compliance services.
  • Perform work to meet IPS budget requirements and quality standards.
  • Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
  • Other duties as assigned.


Qualifications & Requirements:
  • Bachelor of Science in Engineering.
  • Engineer I: 0-2 years of relevant experience.
  • Engineer II: 2 or more years of relevant experience.
  • Engineer III: 5 or more years of relevant experience.
  • Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA
  • Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software is a plus.
  • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful.


About Us:

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.

 

Specialties

 

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

 

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

 

Attention Search Firms/Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

 

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