Pharma CSV Validation Engineer — Process Qualification Expert

ALWAYSHIRED PTE. LTD.; Singapore; On-site; SGD 50,000 - 60,000; Full time

Job summary

A consulting firm in Singapore is looking for a qualified professional to deliver consulting projects in process-related areas. Responsibilities include preparing critical deliverables, executing qualification protocols, and supporting business development initiatives. Candidates should have a Bachelor's degree in a relevant field and at least two years of experience in a regulated environment. This position favors those with a solid understanding of regulatory requirements and industry best practices.

Qualifications

• Bachelor’s Degree in Life Sciences, Engineering, or a related discipline.
• Minimum 2 years of relevant experience, with consideration for fresh graduates.
• Good understanding of regulatory requirements and industry best practices.

Responsibilities

• Deliver consulting projects in process-related areas.
• Prepare CQ deliverables like URS, risk assessments, and protocols.
• Execute CQ protocols including temperature mapping and CSV testing.

Skills

Project delivery in process-related areas

User Requirement Specifications (URS)

Risk assessments

Data integrity assessments

Qualification/validation protocols

Regulatory requirements understanding

GxP and validation lifecycle knowledge

Familiarity with ASTM E2500 practices

Education

Bachelor's Degree in Life Sciences, Engineering, or related discipline

Tools

Kaye Validator

Ellab temperature mapping systems

Job description

A consulting firm in Singapore is looking for a qualified professional to deliver consulting projects in process-related areas. Responsibilities include preparing critical deliverables, executing qualification protocols, and supporting business development initiatives. Candidates should have a Bachelor's degree in a relevant field and at least two years of experience in a regulated environment. This position favors those with a solid understanding of regulatory requirements and industry best practices.