Engineer

JACKLY ENGINEERING PTE LTD; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

JACKLY ENGINEERING PTE LTD is seeking an experienced CSV validation professional to develop and review validation plans, protocols, and reports for computerized systems within a regulated pharmaceutical environment. The role emphasizes risk assessments, adherence to 21 CFR Part 11 and GAMP 5, and collaboration with IT, QA, and manufacturing teams.

Ideal candidates have 5–8 years in CSV within pharma or related industries, strong documentation skills, and the ability to work independently as well

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.

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.

Skills

CSV validation

Regulatory compliance

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or related

Tools

GxP systems

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.