Validation engineer

GAM-X ENGINEERING SERVICES PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading engineering service company in Singapore is seeking an experienced professional with expertise in Quality Management Systems and validation. You will support automated systems for manufacturing while promoting regulatory compliance and continuous improvement. Candidates should have at least 5 years of relevant experience and hold a Bachelor's or Master's degree. Preferred qualifications include Six Sigma certification and GMP & GDP. This position promises a challenging environment focused on innovation and excellence.

Qualifications

• Minimum 5 years in Quality Management Systems.
• Proficient in leading Validation and Computerized Systems.
• Preferred Six Sigma black and green belt certified.

Responsibilities

• Assist in review and preparation of validation and qualification documents.
• Train all site personnel in validation area.
• Promote GMP awareness and continuous improvement.

Skills

Quality Management Systems

Validation

Computerized Systems/SDLC

Data Integrity

Education

Bachelor’s or Master’s Degree

Tools

GAMP5

Audit Management Software

Job description

Responsibilities

• Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
• Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Assist in review and preparation of process/production equipment validation and computer systems validation
• Review and approval of all Data Integrity – related activities and training including periodic reviews and status report to management
• Improve and add to existing Data Integrity knowledge base, identify training requirements and serve as SME for the same
• Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
• Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
• Hands on Computerized Systems Validation GAMP5/21CFR

Requirements

• Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
• Minimum bachelor’s or master’s degree
• Preferred Six Sigma black and green belt certified as it is mandatory for the project prerequisite.
• GMP & GDP Certificate is mandatory
• Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc.