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NNE

Compare

3.8

based on 107 Reviews

2 NNE Engineer Jobs

CQV Engineer

NNE Pharmaplan

3.8

based on 107 Reviews

7-10 years

Bangalore / Bengaluru

1 vacancy

CQV Engineer

NNE

posted 4d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Automation Testing Project Management Instrumentation Engineering Compensation GMP

+ 3 more

Job Description

As Engineer - C&Q, you ll be working with highly skilled Senior Engineers andEngineers 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

Whoyou are (Preferred Competencies)
Wecare about who you are as a person. In the end, how you work, and your energyis what impacts the effort we do as a team.

As a Biotec h 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 clean utilities) 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.

Themiles you ve walked (Education and Work Experience)
In all positions there are some things that areneeded, and others a bonus. We believe these qualifications are needed for youto do well in this role:

Bachelor s or master s degree in a relevant science, engineering, or pharmaceutical field.
7-10 years of 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.

Employment Type: Full Time, Permanent

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