Senior Validation Specialist (12 months)

Senior Validation Specialist (Quality) 12 months contract

We are seeking an experienced Senior Validation Specialist to support design transfer and validation activities within a highly regulated manufacturing environment. The successful candidate will be responsible for planning, executing, reviewing, and documenting validation activities to ensure compliance with regulatory requirements, company quality standards, and internal Standard Operating Procedures (SOPs).

This is an excellent opportunity for a seasoned validation professional with strong hands-on experience in qualification and validation activities across facilities, equipment, manufacturing processes, and computerized systems.

Key Responsibilities

• Support design transfer activities, including validation and qualification of:
• Facilities, Equipment, Utilities, Materials, Manufacturing processes, Cleaning processes, Computerized systems
• Ensure all validation activities are appropriately planned, executed, documented, and completed in compliance with regulatory requirements and internal SOPs.
• Review and approve validation protocols, reports, and supporting documentation to ensure accuracy, completeness, and regulatory compliance.
• Coordinate with cross-functional stakeholders to support project timelines and validation deliverables.
• Maintain accurate and organized validation records to support regulatory inspections, audits, and quality system requirements.
• Investigate validation-related issues and support the implementation of corrective and preventive actions where required.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and ALCOA+ data integrity principles.

Requirements

• Bachelor's Degree in Engineering, Science, or a related discipline.
• Minimum 10 years of hands-on experience in validation within the pharmaceutical, medical device, biotechnology, or related regulated industry.
• Strong experience in qualification and validation of facilities, equipment, utilities, manufacturing processes, cleaning processes, and computerized systems.
• Good understanding of regulatory requirements, validation methodologies, and quality systems.
• Knowledge of: cGMP, cGDP, ALCOA+ Data Integrity Principles
• Strong communication, interpersonal, and stakeholder management skills.
• Excellent analytical and problem-solving abilities.
• Ability to prioritize tasks and work effectively within project timelines.

Preferred Qualifications

• Experience supporting design transfer or technology transfer projects.
• Experience managing regulatory inspections and internal/external audits.
• Familiarity with validation lifecycle management and risk-based validation approaches.

Salary range : S$7,000.00 – S$10,000.00

Location : Downtown

Interested applicants, please submit your application to [Confidential Information]

We regret to inform that only shortlisted candidates will be contacted.

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