Location: Bangalore, India
Seniority: 5 to 8 years - Commissioning Engineer
Department Commissioning and Qualification
How you might spend your days (Main Roles & Responsibilities)
As 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 (Preferred Competencies)
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 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
Should have knowledge in process equipment's qualification (upstream downstream or CIP)
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.
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.
5 to 8 years experience 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.
