Quality Engineer (Validation)

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Ensure that change control and validation activities are executed in a timely manner. MAIN RESPONSIBILITIES Comply to all policies and standards. Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies. Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes. Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests. Perform root cause analysis and identify corrective and preventive actions in addressing quality events Support resolution of validation events and escalate concerns in a timely manner. Support in equipment and process walkdowns Weekly, Monthly and Quarterly reporting as required for own business area Support Monthly and Quarterly Quality Management Review (QMR) and Business Management Review (BMR) Coordinate and support periodic plant stoppage activities related to validation and change control functions Develop and execute business area improvement projects Participate in internal and external audits Participate in division and site projects, improvement activities and technical sharing platforms Any other ad-hoc requests as assigned by the supervisor. QUALIFICATIONS Education Degree in a Science or Engineering discipline. Diploma in a Science or Engineering discipline with minimum 3 years working experience. Experience/Background Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry. Familiarity in developing SOPs and work flows Knowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.). Familiarity with international and technical standards is a plus (ISO, FSSC etc) Proficient in Microsoft applications (Powerpoint, Word, Excel) Team player with initiative, drive, good communication skills and a strong command of written English Ability to do data analysis using Minitab, JMP is a plus. Experience in manufacturing process design and equipment design or application is a plus. Proven problem-solving capability, customer focus and commitment to continuous improvement. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: Singapore > Singapore : SN01 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Yes SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)