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.
