Validation Engineer (Pharmaceutical, CSV / CQV)

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.

Requirement:

• 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.

Interested candidates please apply online or send your latest CV to

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

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