Advanced CQV Engineer

Job Summary

Make your ability count at NNE

We are experts in end-to-end pharma engineering, and our success is built on our relationships, both with our colleagues and our customers. If you want to work on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be.

Location: Bangalore, India. Seniority: 9 -13 years. Department: Commissioning and Qualification.

Responsibilities

How you might spend your days (Main Roles Responsibilities)

As Advanced Engineer - CQ, you ll be working with highly skilled Senior Engineers and Engineers and still growing across Denmark and Indian team s where you ll:

• Would like to help making complex biopharma facilities more sustainable.
• Driving the project with Science and Risk based Validation (SRV) concept.
• Work very closely with our customers.
• Have knowledge of commissioning of Process Utility systems and collaborate with multi-discipline teams to integrate piping distribution, instrumentation and automation services, facilitate and ensure right commissioning across the project.
• Good technical knowledge on Piping codes and standards.
• Should have knowledge on terminologies of symbols used in PID.
• Perform CQ activities in smaller cross-disciplinary teams
• Align quality and validation concept with customer s quality system validation concept
• Define scope of CQ activities in project and scope of work within quality work package incl. relevant CQ activities
• Ensure changes to scope are brought to the attention of Project Management.
• Ensure interfaces to and coordination with other disciplines and compliance with codes, regulations and relevant Procedures.
• Ensure right level of commissioning processes so as to have smooth qualification phases
• Generate validation deliverables like commissioning , protocols etc
• Ensure CQ documentation is in compliance with GMP and GEP (incl. ASTM E2500).
• Conduct follow-up on QAP planned CQ activities

Who you are

We care about who you are as a person. In the end, how you work, and your energy is what impacts the effort we do as a team. As a Biotech person, you

Experience in executing pre-commissioning activities like walkdown ,mechanical completion, partial stat-up of a distribution system, etc

• Should have experience in clean utility qualification
• Hands on experience in CQ activities of process equipment s (upstream and downstream and CIP) in DS facility qualification
• Should have experience in validation deliverables like URS, PIDs, FAT, SAT, generation execution, etc
• Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures.
• Responsible for operational or administrative deliverables where output is complex.
• Can work independently, or alternatively project work in small projects
• Expected to support more senior staff in parts of larger processes or project on project deliverables
• Expected to adapt procedures, processes, tools, equipment, or techniques to accomplish the correct output of specific assigned tasks.
• Expected to, take initiative, prioritize, and plan the work to reach deadlines
• Make operational decisions through a choice between known alternatives.
• Demonstrates subject matter knowledge

Education and Experience

The miles you ve walked (Education and Work Experience)

In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role:

• Bachelor s or master s degree in a relevant science, engineering, or pharmaceutical field.
• Experience in performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment and utility qualification.
• Should have knowledge with recent edition of ISPE CQ and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 21 CFR 11 and ICH guidelines.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.