Validation Manager (Design Transfer) 12 months contract

PERSOL SINGAPORE PTE. LTD.; Singapore; On-site; SGD 78,000 - 112,000; Full time

Job summary

PERSOL SINGAPORE PTE. LTD. is seeking an experienced Validation Manager to lead design transfer and validation in a highly regulated manufacturing environment in Singapore.

You will plan, execute, review, and document validation activities to ensure compliance with regulatory requirements, SOPs, and company quality standards. The role spans qualification of facilities, equipment, utilities, processes, cleaning, and computerized systems, with a focus on cGMP, cGDP, and ALCOA+ data integrity.

Qualifications

• Bachelor's degree in engineering/science or related field.
• 10+ years hands-on validation experience in regulated industries.
• Experience validating facilities, equipment, utilities, processes, cleaning and computerised systems.
• Knowledge of regulatory requirements, validation methodologies, and quality systems.
• Familiarity with cGMP, cGDP, ALCOA+ data integrity.

Responsibilities

• Plan, execute, review and document validation activities to ensure regulatory compliance.
• Support design transfer validation and qualification of facilities, equipment, utilities, materials, processes, cleaning and computerized systems.
• Review and approve validation protocols and reports.
• Coordinate with cross-functional stakeholders to meet timelines.
• Maintain validation records for inspections and audits.
• Investigate validation issues and support CAPA implementations.
• Ensure adherence to cGMP, cGDP and ALCOA+ data integrity principles.

Skills

Communication

Interpersonal skills

Analytical thinking

Problem solving

Prioritization

Education

Bachelor's Degree in Engineering/Science

Job description

About the Role

We are seeking an experienced Validation Manager 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.

Why Join Us?

• Opportunity to work on impactful design transfer and validation projects.
• Collaborative and quality-focused work environment.
• Exposure to highly regulated pharmaceutical/medical device manufacturing operations.
• Work alongside experienced cross-functional teams in engineering, quality, and operations.

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

Location : Downtown