Pharma Validation Engineer: CQV & CSV Leader

ALWAYSHIRED PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ALWAYSHIRED PTE. LTD.

in Singapore seeks an experienced CQV/CSV professional to deliver laboratory equipment commissioning, qualification and computer system validation for pharma and medical device clients. You will lead projects, document results, and ensure compliance with 21 CFR Part 11/Annex 11, ISPE GAMP5, and data integrity standards, while collaborating with cross‑functional teams to optimise lab operations.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Minimum 2 years of experience in regulated pharma/medical device environments.
• Experience CQ and/or equipment system ownership.
• Experience configuring LIMS/LES/ELN/CDS.
• Knowledge of 21 CFR Part 11 and Annex 11; ISPE GAMP5.

Responsibilities

• Lead the delivery of laboratory CQV/CSV services for pharma and medical device clients.
• Implement LIMS/ELN/CDS to optimise operations and data management.
• Provide data integrity and CSV services for QC equipment and systems.
• Draft and review CQV/CSV documentation (URS, risk assessments, ERES, IOQ, RTM).
• Execute CQ and CSV activities.
• Support integration of laboratory equipment with networks and enterprise systems.
• Manage deviation, CAPA, and change control related to QC equipment and systems.
• Draft/revise SOPs and related documents to support quality systems.

Skills

Analytical thinking

Detail-oriented

Regulatory knowledge

Education

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

Tools

LIMS (Labware)

LES (Biovia LES)

ELN

CDS (Empower, OpenLab)

Job description

ALWAYSHIRED PTE. LTD.

in Singapore seeks an experienced CQV/CSV professional to deliver laboratory equipment commissioning, qualification and computer system validation for pharma and medical device clients. You will lead projects, document results, and ensure compliance with 21 CFR Part 11/Annex 11, ISPE GAMP5, and data integrity standards, while collaborating with cross‑functional teams to optimise lab operations.