ENGINEER

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

Job summary

JACKLY ENGINEERING PTE LTD in Singapore is seeking a seasoned CSV validation professional to develop and review validation plans, protocols, and reports for computerized systems used in pharmaceutical manufacturing.

You will collaborate with IT, Quality Assurance, and Manufacturing to ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, while maintaining documentation and traceability throughout the lifecycle.

Qualifications

• Bachelor’s degree in a relevant field.
• 5–8 years of experience in CSV within pharmaceutical manufacturing or regulated industries.
• Strong knowledge of GxP, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
• Experience validating PLC/SCADA, MES, or other pharma 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 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

GxP knowledge

Documentation

Cross-functional collaboration

Independent work

Education

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

Tools

PLC/SCADA validation

MES validation

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.