Full Time QC Equipment Qualification Engineer Jobs, Salary up to SGD 8,000 in PQE SINGAPORE PTE. LTD. - Maukerja

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.

WHO WE ARE
PQE Group is a women-owned, ISO 9001:2015 and ISO/IEC 27001:2022 certified technology solutions and compliance consulting company, offering comprehensive quality solutions for GCP, GLP, GMP, GVP, and GDP areas in the Life Sciences industry. With over 2,000 employees (40% of whom are women) across 40+ offices worldwide, we bring together more than 50 nationalities and operate in 25+ languages.

We are dedicated to creating value for our customers by leveraging our multidisciplinary teams and expertise, enabling them to achieve and maintain compliance with the latest regulations while optimizing processes and ensuring data integrity.

Our commitment to quality, security and innovation, backed by international certifications and decades of experience, allows us to provide scalable, tailored solutions that meet the evolving needs of the life sciences sector.

WHAT WE DO
Since 1998, PQE Group has been delivering turnkey quality solutions across the entire product qualitylifecycle, focusing on offering cost-effectiveness without compromising quality. Our broad service portfolio and extensive experience have made us the trusted partner for global corporations, as well as small and medium-sized enterprises. To date, we have completed over 25,000 projects worldwide for 1,400+ clients in the pharmaceutical, medical device, SaMD, biotech, veterinary and other life science related sub-industries.

WHY US?
Our proven combination of expertise in project management, wide-ranging services, and exceptionalcost-effectiveness makes PQE Group a valuable partner for businesses of all sizes. We help our clients achieve compliance, ensuring that our solutions drive success.

WHERE WE’RE GOING
At PQE Group, we are committed to fostering positive change in the communities and environments where we operate. Through our corporate social responsibility goals, we promote sustainable development, gender equality, environmental protection, and health and safety initiatives. Our partnerships with programs and charity organizations globally reflect our dedication to driving social and environmental impact.

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 andinteract 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.

Apply now and take the first step towards an amazing future with us.