Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Location Joo Koon Circle, Singapore How will you make an impact? You will provide validation expertise and supervision of multiple complex activities for process, equipment and/or computer validation associated with the new plant set up and subsequently products produced by the Company.

• Serves as a principle technical authority with regards to validation activities associated with equipment, utilities, computers, and processes
• Serves as the validation authority for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation
• Ensure validation activities are compliant with the procedures
• Maintain the site in validated status
• Review and approve all validation documents generated as part new plant set up
• Maintain annual validation planner Leads multiple sophisticated validation activities associated with computers, equipment, and processes
• Prepares, reviews and approves production, validation, audit reports, risk assessments, and/or master batch record documents, procedures, and rationales
• Coordinates validation associated audit activities; establish rationales and technical defense positions
• Negotiates with clients the validation requirements for projects. Resolves significant validation, product and regulatory issues. Plans and establishes technical communications, document flow, testing requirements, and resources vital to complete the validation of a system
• Supports systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention
• Participates as the validation representative in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance and interdepartmental consistency within the validation program
• Assures compliance to all applicable laws by proactively interpreting regulatory and compliance requirements as related to validation
• Maintains current knowledge and serve as a technical resource for emerging trends and technologies

• Understand emergency procedures and comply with safe systems of work
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

• Bachelor’s degree in Engineering, Life Sciences, or other related area of study

• 4+ years of validation experience within pharmaceutical or other regulated industry
• Experience working directly with customers highly preferred
• Experience working within a sterile environment preferred
• Experience in Track wise preferred
• Project management experience

• Multitasking skills
• Excellent communication – both written and verbal
• Time-management skills
• Ability to work independently and adhere to critical timelines
• Ability to work in a sterile environment.