We are seeking highly skilled Commissioning, Qualification, and Validation (CQV) Engineers to provide risk-based CQV services for pharmaceutical and biopharmaceutical clients. This role offers opportunities to work across various areas, including process equipment, CIP/SIP (Clean-In-Place/Sterilize-In-Place), and process manufacturing systems, with a focus on maintaining compliance with regulatory standards.
Key Focus Areas:
- CQV for Facilities, HVAC, and Equipment
- CQV for Cleaning Validation
Responsibilities:
- Develop risk assessments, system impact assessments, protocols, and reports to support qualification and validation requirements, in line with regulatory standards and industry best practices.
- Create validation protocols using a science and risk-based approach to ensure compliance with regulatory requirements.
- Review, analyze, interpret, and summarize system and process performance data from executed activities for reporting and presentations to management.
- Investigate deviations, prepare detailed investigation reports, and create summary reports to ensure clear documentation of issues and their resolutions.
- Apply good judgment within defined practices and policies to select appropriate methods and techniques for obtaining solutions.
- Author or support the creation of test scripts for commissioning and qualification (CQ) of facilities, HVAC systems, manufacturing or analytical equipment.
- Conduct cleaning validation studies to ensure processes meet stringent regulatory requirements.
- Author or execute test scripts for DeltaV batch recipe testing, ensuring seamless integration with production processes.
- Draft DeltaV batch recipes, ensuring alignment with manufacturing specifications and process requirements.
Requirements:
- Experience with pharmaceutical and biopharmaceutical processes, including commissioning, qualification, and validation.
- Knowledge of DeltaV batch processes and recipe creation/testing is highly desirable.
- Proven expertise in facilities, HVAC, equipment, or cleaning validation is required for the respective roles.
- Strong analytical and problem-solving skills with a good understanding of industry regulations and standards.
- Experience with risk-based validation approaches and developing protocols in compliance with regulatory requirements.
Interested candidates please apply online or send your latest CV to [email protected]
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
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