Commissioning Engineer

at  NNE

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.

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 activitie

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

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