Quality Engineer – Validation

About the role

The Quality Engineer (Validation) will ensure that change control and validation activities are executed in a timely manner at Abbott’s Tuas manufacturing site. You will work closely with cross‑functional teams to maintain compliance with all relevant policies and standards.

Key responsibilities

• Develop, execute and review validation protocols and related documentation according to Abbott procedures.
• Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.
• Manage site Validation Review Board (VRB) processes and approve change controls and validation change requests.
• Perform root‑cause analysis, identify corrective and preventive actions, and support resolution of validation events.
• Conduct equipment and process walk‑downs, and coordinate periodic plant stoppage activities related to validation.
• Prepare weekly, monthly and quarterly reports for the business area and support Quality Management Review (QMR) and Business Management Review (BMR).
• Develop and execute improvement projects, and participate in internal and external audits.

Required profile

• Degree in a Science or Engineering discipline, or a Diploma with a minimum of 3 years of relevant experience.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical environment.
• Familiarity with SOP development, problem‑solving tools (6M Analysis, Fishbone, 5 Whys) and international standards such as ISO or FSSC.
• Strong written English communication skills and a proactive, team‑oriented attitude.

Required skills

• GMP and GDP compliance
• Failure Mode Effects Analysis (FMEA)
• Problem‑solving tools: 6M Analysis, Fishbone, 5 Whys
• ISO and FSSC standards awareness
• Microsoft PowerPoint, Word and Excel
• Data analysis using Minitab or JMP (preferred)
• Validation protocol development and change‑control management
• Root‑cause analysis and corrective‑preventive action (CAPA) processes

What we offer

• Career development opportunities within a global, innovative company.
• Recognition as a great place to work and a leader in diversity and inclusion.
• Support for work‑life balance and personal growth.