Commissioning Engineer

Role & responsibilities:

• Perform commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities in the BU.
• Responsible for timely preparation, review and approval of URS, DQ, IQ, OQ and PQ protocols, and reports along with operation staff and QA.
• Responsible for timely preparation, review and approval of other validation documents.
• Coordinate the Calibration Program, Preventive Maintenance Program and Alarm Management for the biopharmaceutical manufacturing facilities.
• Responsible for appropriate planning and timely execution along with review and approval of reports.
• Responsible for robust and optimal practices for maintenance and calibration program to upkeep the facilities.
• Responsible for establishment of appropriate Alarm Management system and implementation.
• Perform investigation for equipment failure to identify root cause and propose and implement appropriate CAPA to prevent reoccurrence.
• Participate in large & small capital projects; finalize conceptual design, basic design and detailed engineering design along with E&M team.
• Perform regular facility walkthroughs and internal audit for Manufacturing Plants and Operations Function to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
• Perform Risk Management for Biologics Operations covering following elements and lead proposal and implementation of appropriate risk mitigation actions (CAPA).
• Quality and Compliance Risks Operational Risks of Data Integrity Risks •
• Perform and support timely preparation, review and approval of Standard Operating Procedures (EOP, IOP and SOP) and review of executed records.

Preferred candidate profile:

Engineering Commissioning & Qualification in Biopharmaceutical Industry.