10.0 - 15.0 years

9 - 13 Lacs

Bengaluru

Work from Office

Department Commissioning and Qualification (USP / DSP / Clean utilities) How you might spend your days (Main Roles & Responsibilities) As Senior Engineer C&Q, youll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian teamswhere youll: 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 high knowledge of process equipments systems Should have knowledge on terminologies of symbols used in PID. Execute C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendors, and QA) of the project organization Align quality and validation concept with customers 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. Generate validation deliverables like IQ, OQ, PQ protocols and reports, etc. Act as Smarter Execution consultant for Project Members. 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 yourenergy is what impacts the effort we do as a team. As a Biotech person,you: Thrives in a fast-paced environment with many concurrent tasks. Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns. Hands on experience in planning / directing C&Q activities of process equipments (upstream and downstream and clean utilities) in DS facility qualification Should have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc. Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures. The miles youve 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: Bachelors or masters degree in a relevant science, engineering, or pharmaceutical field. 10-15 years' experience performing commissioning and / or qualification activities in an FDA regulated industry. Have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc. 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.

Posted 2 months ago

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