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5,161
Manufacturing jobs in Singapore
Senior Validation & Compliance Specialist
CUTE MARINE SERVICES PTE. LTD.
Singapore
On-site
SGD 80,000 - 120,000
4 days ago
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Manager Engineering (Planning & Scheduling)
AMGEN SINGAPORE PTE. LTD.
Singapore
On-site
SGD 90,000 - 110,000
4 days ago
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General Manager - IPO
Kyocera Asia Pacific Pte Ltd
Singapore
On-site
SGD 90,000 - 130,000
4 days ago
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PROJECT MANAGEMENT
TSET TECHNOLOGY PTE. LTD.
Singapore
On-site
SGD 60,000 - 80,000
4 days ago
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Technician (Instrument & Electrical/Gross Up $6k)
NOVEXX PTE. LTD.
Singapore
On-site
SGD 60,000 - 80,000
4 days ago
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Discover more opportunities than anywhere else. Find more jobs nowProduction Executive | West
Adecco Personnel Pte Ltd (Perm)
Singapore
On-site
SGD 65,000 - 85,000
5 days ago
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Metrology Process Engineer
United Microelectronics Corporation (UMC)
Singapore
On-site
SGD 80,000 - 100,000
5 days ago
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Product Quality Engineer
Doodle Labs LLC
Singapore
On-site
SGD 50,000 - 70,000
5 days ago
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Connect with headhunters to apply for similar jobsPhotoligraphy Process Engineer
United Microelectronics Corporation (UMC)
Singapore
On-site
SGD 60,000 - 80,000
6 days ago
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Wet Equipment Engineer/ Senior Engineer
Systems on Silicon Manufacturing Company Pte Ltd (SSMC)
Singapore
On-site
SGD 45,000 - 65,000
6 days ago
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Principal System Analyst, IT
VENTURE CORPORATION LIMITED
Singapore
On-site
SGD 90,000 - 120,000
6 days ago
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Biologics Manufacturing Associate Director
AstraZeneca Singapore Pte Ltd
Singapore
On-site
SGD 60,000 - 80,000
6 days ago
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Senior Staff Industrial Engineer
Infineon Technologies
Singapore
On-site
SGD 70,000 - 90,000
6 days ago
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Principal Engineer, Procurement
HYPERSCAL SOLUTIONS PTE. LTD.
Singapore
On-site
SGD 60,000 - 90,000
6 days ago
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Technician / Junior Engineer / Engineer
TRANSCENDT PHOENIX SOLUTIONS PTE. LTD.
Singapore
On-site
SGD 30,000 - 45,000
6 days ago
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12 MONTHS PROCESS ENGINEER (CONVERTIBLE)
Ambition Singapore
Singapore
On-site
SGD 80,000 - 100,000
6 days ago
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Process & Design Engineer: Optimize Yield, Scale Production
ELITEZ & ASSOCIATES PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
7 days ago
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Engineers ( Process / Maintenance / Design )
ELITEZ & ASSOCIATES PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
7 days ago
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Traineeship - Production Engineering
West Pharmaceutical Services
Singapore
On-site
SGD 30,000 - 50,000
7 days ago
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Technical Support Executive (Purchaser)
Ravago Manufacturing Singapore Pte Ltd
Singapore
On-site
SGD 50,000 - 70,000
7 days ago
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Senior Finance Manager (High Tech Manufacturing)
Robert Half International Pte Ltd
Singapore
On-site
SGD 60,000 - 80,000
7 days ago
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Senior Validation and Compliance Specialist
CUTE MARINE SERVICES PTE. LTD.
Singapore
On-site
SGD 80,000 - 120,000
Full time
4 days ago
Be an early applicant
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
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.