As Advanced Engineer - C&Q, you ll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian team swhere 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 person. In the end, how you work, and yourenergy 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 WorkExperience)
In all positions there are some things that are needed, and others a bonus. Webelieve 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.
