Engineer CQV

Job :Engineer CQV

Exeperience:710 years

Job Description:

• 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 multidiscipline 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 crossdisciplinary 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 followup on QAP planned C&Q activities

Equcation & Experience:

• Bachelor’s or master’s degree in a relevant science engineering or pharmaceutical field.
• 710 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.
• 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.