ENGINEER

LP CONSTRUCTION & ENGINEERING PTE. LTD.; Singapore; On-site; SGD 100,000 - 150,000; Full time

Job summary

LP CONSTRUCTION & ENGINEERING PTE. LTD. is seeking a seasoned CSV validation professional to develop and review validation plans (IQ/OQ/PQ) and generate related reports for computerized systems in pharma manufacturing.

The role involves risk assessments and ensuring adherence to GxP, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines. You will collaborate with IT, QA, and Manufacturing teams, manage change control and deviations, and support regulatory audits while maintaining comprehensive

Qualifications

• Bachelor-level degree in a relevant field (pharma, engineering, life sciences, or CS).
• 5-8 years CSV experience in pharmaceutical manufacturing or regulated industries.
• Strong knowledge of GxP, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.

Responsibilities

• Develop and review validation plans, IQ/OQ/PQ, and reports for computerized systems.
• Perform risk assessments and impact analysis related to system validation.
• Ensure compliance with FDA/EU guidelines and GAMP 5.
• Collaborate with IT, QA, and Manufacturing to support system qualification and validation.

Skills

Regulatory knowledge

Documentation

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field

Tools

PLC SCADA

MES

Validation software

Job description

Key Responsibilities:

• Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
• Perform risk assessments and impact analysis related to system validation.
• Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
• Manage change control and deviation investigations related to validated systems.
• Support audits and inspections by regulatory authorities.
• Maintain validation documentation and ensure traceability throughout the system lifecycle.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
• 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
• Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
• Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
• Excellent documentation and communication skills.
• Ability to work independently and in cross-functional teams.