Senior Validation Specialist – cGMP/Design Transfer, 18-month, CBD

Job Summary:

We are seeking an experienced Senior Validation Specialist to support product and process transfer projects to third-party manufacturing partners. This role will be responsible for planning, coordinating, and overseeing validation activities related to facilities, equipment, utilities, manufacturing processes, cleaning processes, and computerized systems, ensuring compliance with regulatory requirements and internal quality standards.

The successful candidate will work closely withcross-functional teams and external manufacturing partners to ensure the smooth execution of technology transfer and validation activities.

As part of project execution, the role will require frequent travel to Johor Bahru, Malaysia to support validation and product transfer activities at the third-party manufacturing site. Accommodation and meal expenses for extended stays will be covered by the company.

Job Scope:

• Lead and support product and process transfer projects to third-party manufacturing partners, ensuring a smooth and compliant transition from internal operations to external manufacturing sites.
• Plan, coordinate, and execute validation activities related to design transfer, including validation of facilities, equipment, utilities, materials, manufacturing processes, cleaning processes, and computerized systems.
• Ensure all validation activities are properly planned, executed, and documented in accordance with regulatory requirements, company quality standards, and internal SOPs.
• Review and approve validation documentation, including protocols, reports, and supporting technical documents to ensure completeness, accuracy, and regulatory compliance.
• Work closely with cross-functional teams such as Engineering, Quality Assurance, Manufacturing, and external manufacturing partners to ensure successful technology transfer and project delivery.
• Identify and resolve technical and compliance issues during the validation and transfer process while ensuring adherence to project timelines.
• Maintain well-organized validation documentation and records to support regulatory inspections, internal audits, and quality compliance.
• Provide on-site support and coordination during validation and transfer activities at third-party manufacturing sites when required.

Requirements:

• Bachelor’s degree in Science, Engineering, or a related discipline.
• Minimum 10 years of hands-on experience in validation within a regulated industry such as pharmaceutical, biotechnology, or medical device manufacturing.
• Knowledge of validation lifecycle, cGMP, cGDP, and ALCOA+ data integrity principles.
• Experience supporting design transfer, technology transfer, or manufacturing transfer projects.
• Communication, problem-solving, and stakeholder management skills, with the ability to collaborate across cross-functional teams and external partners.
• Ability to manage multiple validation activities and adhere to project timelines in a fast-paced project environment.

Additional Information:

• Salary – Up to S$10K + 1.5-month bonus
• Contract duration: 18-month contract, extendable or convertible to perm
• Commencement Date: Immediate
• Working days and hours: Monday to Friday, 8.30am to 5.30pm
• Location: Bugis, frequent traveling to Johor Malaysia