Commissioning & Qualification Advanced CQV Engineer

Commissioning & Qualification -Advanced CQV Engineer

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.

Why should you join us
Whichever dream or focus you have; NNE offers exciting career opportunities in a truly passionate and high-powered working environment where you will join our Commissioning and Qualification team and will be part of Project Management team and Project Execution dedicated to deliver the largest Biopharmaceutical facility to our customers.

NNE have a work culture that’s shaped in value the employees for their unique skills backgrounds and perspectives which they bring to the table and work continuously in bringing out the best and offering opportunities for development and promoting sustainable career opportunity within the company. As a Commissioning and Qualification team you are going to handle different IT documentation platforms during the project lifecycle. For the right candidates there will be possibilities for business travels or relocation to Denmark.

Location: Bangalore India.

Seniority: 9 -13 years
Department Commissioning and Qualification

How you might spend your days (Main Roles & Responsibilities)
As Advanced Engineer – C&Q 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 C&Q activities in smaller cross-disciplinary teams:
• Align quality and validation concept with customer’s quality system & validation concept
• Define scope of C&Q activities in project and scope of work within quality work package incl. relevant C&Q 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 C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
• Conduct follow-up on QAP planned C&Q activities

Who you are
We care about who you are as a 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 C&Q activities of process equipment’s (upstream and downstream and CIP) in DS facility qualification
• Should have experience in validation deliverables like URS P&IDs 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.

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 C&Q and GAMP and regulatory guidelines USFDA EU GMP Annexure 11 & 21 CFR 11 and ICH guidelines.

Required Skills:

Commissioning Qualification Process & Utility systems commissioning Multi-discipline team collaboration Piping codes and standards PID terminologies Quality and validation concept alignment Scope definition of C&Q activities Coordination with other disciplines Compliance with codes and regulations Commissioning processes Validation deliverables generation GMP compliance GEP compliance ASTM E2500 QAP follow-up Pre-commissioning activities Walkdown Mechanical completion Partial start-up Clean utility qualification C&Q activities of process equipment Upstream and downstream process CIP Facility qualification Validation deliverables: URS P&IDs FAT SAT Generation & execution Communication skills Collaboration skills Project work Initiative Prioritization Planning Operational decisions Subject matter knowledge ISPE C&Q GAMP USFDA regulatory guidelines EU GMP Annexure 11 21 CFR 11 ICH guidelines