Validation Engineer, CSV (Pharmaceutical)

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

Responsibilities

• Deliver consulting projects in process-related areas, including but not limited to Equipment Qualification, Computer System Validation (CSV), and other qualification and validation disciplines.

• Prepare CQ deliverables such as User Requirement Specifications (URS), risk assessments, data integrity assessments, and qualification/validation protocols.

• Execute CQ protocols including temperature mapping and CSV testing/verification.

• Support business development and service initiatives as directed by the management.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, or a related discipline.

• Minimum 2 years of relevant experience in the pharmaceutical, medical device, or related regulated environment.

• Fresh graduates with internship experience in the pharmaceutical or medical device industry and relevant exposure may be considered for a Junior role.

• Good understanding of regulatory requirements and industry best practices (GxP, validation lifecycle, data integrity).

• Hands‑on experience with Kaye Validator or Ellab temperature mapping systems is an added advantage.

• Familiarity with ASTM E2500 practices will be preferred.

Interested candidates please apply online or send your latest CV to [e-mail]

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

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