Senior Validation & Design Transfer Lead

PERSOL

Singapore

On-site

SGD 120,000 - 180,000

Full time

14 days+
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Job summary

PERSOL seeks an experienced Validation Manager (Design Transfer) to lead validation activities in a regulated manufacturing environment in Singapore. The role covers planning, executing, and documenting validation for facilities, equipment, utilities, processes, and computerized systems to ensure cGMP, cGDP, and ALCOA+ data integrity.

You will review validation protocols and reports, coordinate with cross-functional teams, and support regulatory inspections and audits, driving timely project

Qualifications

  • Bachelor's degree in Engineering, Science, or a related discipline.
  • Minimum 10 years of hands-on validation experience in a regulated industry (pharmaceuticals/biotech/medical devices).
  • Strong experience in qualification and validation of facilities, equipment, utilities, manufacturing and cleaning processes, and computerized systems.
  • Solid understanding of regulatory requirements, validation methodologies, and quality systems.
  • Knowledge of cGMP, cGDP, ALCOA+ Data Integrity Principles.
  • Excellent communication, interpersonal, and stakeholder management skills.

Responsibilities

  • Support design transfer activities, including validation and qualification of facilities, equipment, utilities, materials, manufacturing processes, cleaning processes, and 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 cGMP, cGDP, and ALCOA+ data integrity principles.

Skills

Communication skills
Interpersonal skills
Stakeholder management
Analytical and problem solving

Education

Bachelor's degree in Engineering, Science or related field

Job description

PERSOL seeks an experienced Validation Manager (Design Transfer) to lead validation activities in a regulated manufacturing environment in Singapore. The role covers planning, executing, and documenting validation for facilities, equipment, utilities, processes, and computerized systems to ensure cGMP, cGDP, and ALCOA+ data integrity.

You will review validation protocols and reports, coordinate with cross-functional teams, and support regulatory inspections and audits, driving timely project

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