Validation Engineer

at  No Deviation Pte Ltd

About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That’s why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are looking for a Validation Engineer to manage and execute validation activities, including equipment, utilities, and facility qualifications. You will develop and support the creation of validation documentation, apply a science-based approach to validation, analyze data, and assist with investigating deviations. Collaboration with cross-functional teams and adherence to safety, quality, and regulatory standards are key aspects of this role to ensure the successful delivery of validation projects.

Key Responsibilities

• Lead and complete critical validation activities, including equipment and utilities qualification, facility qualification (aligned with EU Annex 1), and thermal mapping for controlled temperature chambers to ensure precise temperature control and compliance.
• Perform thorough thermal mapping as part of the qualification process for temperature-controlled chambers, ensuring that all temperature conditions are validated according to industry and regulatory standards.
• Develop and support the creation of essential validation documentation, such as Risk Assessments, plans, protocols, and reports.
• Apply a science-driven and risk-based approach to all validation activities.
• Analyze, interpret, and summarize data from thermal mapping and other validation studies to ensure compliance and operational accuracy.
• Investigate and support the resolution of deviations or non-conformities identified during thermal mapping or other validation activities.
• Collaborate effectively with stakeholders, including cross-functional teams, clients, and corporate functions, to ensure seamless project delivery.
• Guarantee the safety, quality, and timely completion of thermal mapping and validation projects.
• Ensure adherence to validation lifecycle processes (e.g., URS, FAT/SAT, commissioning, IO/PQ protocols) and compliance with international regulatory standards.

Required Qualifications

• Bachelor`s degree in a science or engineering discipline.
• Minimum of 2 years of experience in pharmaceutical CQV.
• Strong understanding of validation lifecycle processes and regulatory guidelines.
• Familiarity with industry best practices for equipment and utilities qualification.
• Fluent in written and spoken English.
• Adaptable to a fast-paced, dynamic work environment.
• A quick learner with a proactive “Can-do” attitude.
• Exceptional time management skills with strong attention to detail.
• Proficiency in presentation and facilitation is an advantage.

Why join us?

• Generous Leave Policy including Elderly Care Leave for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions?
If you’re passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.

• Lead and complete critical validation activities, including equipment and utilities qualification, facility qualification (aligned with EU Annex 1), and thermal mapping for controlled temperature chambers to ensure precise temperature control and compliance.
• Perform thorough thermal mapping as part of the qualification process for temperature-controlled chambers, ensuring that all temperature conditions are validated according to industry and regulatory standards.
• Develop and support the creation of essential validation documentation, such as Risk Assessments, plans, protocols, and reports.
• Apply a science-driven and risk-based approach to all validation activities.
• Analyze, interpret, and summarize data from thermal mapping and other validation studies to ensure compliance and operational accuracy.
• Investigate and support the resolution of deviations or non-conformities identified during thermal mapping or other validation activities.
• Collaborate effectively with stakeholders, including cross-functional teams, clients, and corporate functions, to ensure seamless project delivery.
• Guarantee the safety, quality, and timely completion of thermal mapping and validation projects.
• Ensure adherence to validation lifecycle processes (e.g., URS, FAT/SAT, commissioning, IO/PQ protocols) and compliance with international regulatory standards