Validation Engineer (Pharmaceutical, CSV / CQV)

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

Job Summary

Deliver laboratory equipment commissioning and qualification (CQ) and computer system validation (CSV) services to pharmaceutical and medical device clients, driving compliance and operational excellence through strategic implementation and technical leadership.

Responsibilities

• Lead the delivery of laboratory equipment Commissioning and Qualification (CQ) services to pharmaceutical and medical device clients.
• Implement laboratory enterprise systems such as LES and LIMS for pharmaceutical and medical device clients to optimize laboratory operations and data management.
• Provide Data Integrity (DI) and Computer System Validation (CSV) services for quality control (QC) equipment and system introductions.
• Draft and review CQV and CSV documentation including User Requirement Specifications (URS), risk assessments, audit trail assessments, Electronic Records and Electronic Signatures (ERES) assessments, Installation/Operational Qualification (IOQ) protocols, specifications, and Requirements Traceability Matrices (RTM).
• Execute CQ and CSV activities.
• Support integration of laboratory equipment with other systems such as networks, manufacturing systems, and enterprise systems to enable seamless data flow and operational efficiency.
• Manage deviation and non-conformance investigations, Corrective and Preventive Actions (CAPA), and change control processes related to QC equipment and systems.
• Draft, revise, and review Standard Operating Procedures (SOPs), forms, and related operational and maintenance documents to support laboratory quality systems and compliance.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum 2 years of experience working in pharmaceutical, medical device, or related regulated environments.
• Experience in performing QC equipment CQ and / or becoming equipment system owner.
• Experience configuring laboratory systems such as LIMS (e.g., Labware), LES (e.g., Biovia LES), Electronic Laboratory Notebooks (ELN), and Chromatography Data Systems (CDS) (e.g., Empower, OpenLab) will be an added advantage.
• Knowledge of computerized system regulatory requirements including 21 CFR Part 11 and Annex 11, and industry best practices such as ISPE GAMP5.
• Experience qualifying laboratory equipment integrated with computerized systems in pharmaceutical or medical device environments.