Senior Validation Specialist
1 week ago
Senior Validation Specialist.
At PQE Group, we are seeking a skilled and experienced Senior Validation Specialist to join our team in Singapore. As a key member of our commissioning and qualification team, you will play a vital role in ensuring the successful delivery of projects across various industries.
Key Responsibilities:
• Support the development and review of commissioning and qualification protocols to ensure alignment with project requirements.
• Coordinate and track commissioning and qualification activities to meet project timelines and budgets.
• Collaborate with cross-functional teams to deliver seamless execution of commissioning and qualification activities.
• Identify and resolve issues or delays related to commissioning and qualification processes.
• Manage commissioning and qualification activities for HVAC systems, bioutilities, and thermal mapping.
• Conduct sampling as part of the qualification process.
• Perform activities related to autoclaves, Biological Safety Cabinets (BSCs), and VBEs.
• Execute CTU activities using Ellab systems for monitoring and validation purposes.
Requirements:
• 5-10 years of experience in commissioning and qualification activities within the biotechnology or pharmaceutical industries.
• Hands-on experience with the commissioning and qualification of site facilities, HVAC, utilities, equipment, and systems.
• Experience in thermal mapping and sampling consultancy.
• Familiarity with autoclaves, BSCs, and VBEs.
• Knowledge of CTU activities and Ellab monitoring systems.
• Strong understanding of regulatory requirements and compliance standards (e.g., GMP, FDA, EMA guidelines) relevant to the industry.
• Exceptional organizational, coordination, and problem-solving skills.
What We Offer:
• Opportunity to work on international projects and collaborate with colleagues from diverse backgrounds.
• Chance to improve your skills and expertise in a dynamic and challenging environment.
• Competitive compensation and benefits package.
How to Apply:
Submit your application, including your resume and cover letter, to express your interest in this exciting opportunity. We look forward to reviewing your application and discussing your qualifications further.
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