Advanced CQV Engineer

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.