QC Equipment qualification Engineer

PQE Group; Singapore; On-site; SGD 60,000 - 120,000; Full time

Job summary

PQE Group in Singapore seeks a Validation consultant – QC Laboratory Equipment to lead IQ/OQ/PQ, DQ and CSV activities for QC instruments (HPLC, GC, UV-Vis). You will ensure 21 CFR Part 11 compliance, ALCOA+ data integrity, and close collaboration with QA, IT, and external vendors to support regulatory readiness.

The role requires 2–6+ years in equipment qualification and CDS experience with Empower/OpenLab/LIMS, plus a degree in a related science.

Qualifications

• Experience with qualification lifecycle (DQ/IQ/OQ/PQ) for QC laboratory instruments.
• Knowledge of cGMP, GAMP5 and data integrity principles (ALCOA+).
• Ability to write, execute and review validation protocols and risk assessments.
• Strong collaboration with QA, IT and external vendors.

Responsibilities

• Plan, draft and execute full lifecycle validation documentation for QC instruments (e.g., HPLC, GC, UV-Vis).
• Ensure software for analytical equipment complies with 21 CFR Part 11 and related standards.
• Perform risk assessments and gap analyses for lab systems and computerized tools.
• Manage deviations, change controls and periodic system reviews for instrument qualification.

Skills

CQV experience

CSV experience

Analytical thinking

Documentation

Education

Bachelor’s Degree

Tools

Empower

OpenLab

LIMS

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Validation consultant – QC Laboratory Equipment to support our projects in Singapore.

Key Responsibilities:

• Qualification Lifecycle Management: Plan, draft, and execute full lifecycle validation documentation (DQ, IQ, OQ, PQ, URS, Traceability Matrices, and Validation Summary Reports) for QC laboratory instruments (e.g., HPLC, GC, UV-Vis, Dissolution Testers, pH Meters, Balances).
• Computerized Systems Compliance: Ensure analytical equipment controlling software (e.g., Empower, OpenLab, LIMS) complies with 21 CFR Part 11, EU Annex 11, and Data Integrity principles (ALCOA+).
• Risk Assessments & Compliance: Perform Quality Risk Assessments (FMEA / GAMP5) and gap assessments for existing and new laboratory computerized systems.
• Routine Compliance Activities: Execute Periodic System Reviews (PSR), Audit Trail reviews, User Access Management, and backup/restore verification for laboratory systems.
• Deviations & Change Control: Manage and investigate qualification deviations, non-conformances, and Out-of-Specification (OOS) events related to equipment qualification. Initiate and manage Change Control protocols for system upgrades or modifications.
• Cross-functional Collaboration: Work closely with QC Analysts, Quality Assurance (QA), IT, and external vendors to support site startup, instrument onboarding, and regulatory audit readiness.

About you:

• Experience: 2 to 6+ years of hands-on experience in Equipment Qualification (CQV) and Computer System Validation (CSV) within a regulated pharmaceutical or biotech environment.
• Technical Expertise: Strong background in qualifying QC laboratory analytical instruments and familiarity with Chromatography Data Systems (CDS) like Empower, OpenLab, or LIMS.
• Regulatory Knowledge: Solid understanding of cGMP, GAMP5, Data Integrity (ALCOA+ principles), and 21 CFR Part 11 guidelines.
• Documentation Skills: Proven ability to independently write, execute, and review high-quality validation protocols, risk assessments, and technical summary reports.
• Soft Skills: Excellent analytical problem-solving skills, strong attention to detail, and the ability to work independently while managing cross-functional technical tasks.
• Education: Bachelor’s Degree in Chemical Engineering, Biotechnology, Chemistry, Pharmacy, Automation, or a related scientific/technical discipline.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.