Senior Validation and Compliance Specialist

CUTE MARINE SERVICES PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading validation service provider in Singapore is seeking a Validation Lead to oversee all validation and qualification activities. The ideal candidate will have 7 to 12 years of experience in regulated pharmaceutical environments, a degree in Engineering, and expertise in Computerized Systems Validation (CSV). The role involves ensuring compliance with global regulatory standards, serving as a Data Integrity Governance Lead, and driving a culture of continuous improvement across operations. Competitive salary and growth opportunities offered.

Qualifications

• Minimum 7 to 12 years of experience in regulated environments.
• Deep knowledge of US FDA, EU GMP, and other regulatory standards.
• Expertise in data integrity frameworks and risk-based validation.

Responsibilities

• Act as Validation Lead for all validation activities.
• Lead Computerized Systems Validation per GAMP 5 and regulatory standards.
• Serve as Data Integrity Governance Lead and manage compliance metrics.

Skills

Validation & Qualification

Computerized Systems Validation (CSV)

Manufacturing Quality Systems

Data Integrity Governance

Regulatory Inspection Handling

Education

Bachelor’s or Master’s degree in Engineering

Tools

GMP & GDP certification

Six Sigma Green Belt or Black Belt certification

Job description

Responsibilities

• Act as the site Validation Lead and Point of Contact for all validation and qualification activities related to facilities, utilities, production equipment, laboratories, and computerized systems.
• Lead and execute, Computerized Systems Validation (CSV) in accordance with GAMP 5, SDLC methodologies, and 21 CFR Part 11, including validation of MES, LIMS, ERP, DCS, PLC/SCADA, and cloud-based systems.
• Provide hands‑on leadership in process equipment validation, including IQ/OQ/PQ, cleaning validation, and process validation for highly automated manufacturing environments.
• Interpret and apply global regulatory requirements, including US FDA, EU GMP, ICH, PIC/S, and local regulatory expectations, with particular emphasis on 21 CFR Parts 11, 210, 211, and 820.
• Serve as the Data Integrity Governance Lead, responsible for review, approval, and oversight of all data integrity–related activities, periodic assessments, remediation plans, and compliance metrics reporting to senior management.
• Develop, enhance, and maintain a robust Data Integrity Knowledge Base, identifying training gaps and acting as the SME for enterprise‑wide training initiatives.
• Drive GMP culture and continuous improvement, promoting regulatory compliance, inspection readiness, and operational excellence across manufacturing and laboratory operations.
• Review, approve, and author complex validation documentation, including VMPs, URS, FRS, RA, protocols, reports, SOPs, and periodic review documentation.
• Lead and support regulatory inspections, internal audits, and external audits, including direct interaction with inspectors and response to observations, deviations, and CAPAs.
• Design and deliver validation and compliance training programs for site personnel and cross‑functional stakeholders.
• Provide expert support for change management, deviation investigations, risk assessments, and root cause analysis related to validated systems.

Requirements

• Minimum 7 to 12 year of progressive experience in regulated pharmaceutical, biotechnology, or medical device environments, with demonstrated leadership in:
• Validation & Qualification, Computerized Systems Validation (CSV) SDLC & Change Management, Manufacturing Quality Systems, Data Integrity Governance, Audit & Inspection Readiness, Deviation Management, CAPA, and Documentation Control
• Bachelor’s or Master’s degree in Engineering, or a related technical discipline.
• Six Sigma Green Belt or Black Belt certification – Preferred (project prerequisite).
• GMP & GDP certification good to have
• Deep working knowledge of international regulatory standards and guidance, including but not limited to:
• US FDA, EU GMP, PIC/S, PD 21CFR Parts 11, 210, 211, 821 ISPE, GAMP 5, BPE
• Proven hands‑on expertise in data integrity frameworks, risk‑based validation approaches, and remediation of regulatory findings.
• Demonstrated ability to function as a senior SME, influencing stakeholders across Quality, Engineering, IT, Manufacturing, and Regulatory Affairs. Strong documentation, communication, and regulatory inspection handling skills