Validation Engineer Required – Singapore – Beverage Plant Expansion (Contract Engagement)
The Project: Capex Value – $35m SGD Brownfield Project (Plant Expansion) Network Capacity projects
The Location: Singapore
Duration & Working Week: 12 Month contract with extensions up-to 2 years in duration
40 – 45 hours per week minimum
Overtime pay, premium pay for work on weekends, night shifts and PH
Working on behalf of a multidisciplinary project management and design consultancy. This is an international company with a large footprint across the Southeast Asia, New Zealand and Australian markets
Maintain Site Validation Master plan. Responsibilities include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages
Generates the Validation schedule, drives execution of workload and monitors performance to plan and tracks status of validation activities and documentation
Approves validation protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements
Oversee the development and lead the closure of key validation packages / stages. (DQ, IQ, OQ, PQ)
Ensure validation packages are following Quality plan and PGCS standards
Establish and maintain system lifecycle documentation (e.g. Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports
Evaluates data from executed validation protocols and ensures summary reports are generated and approved, Ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables
Establish validation compliance checklists, FAT checklists and others as required.
Develop and present project status updates to relevant stakeholders
Support HAZOP’s, documentation squad checks, risk assessments, design reviews, workshops and other project related activities.
Updating relevant PGCS standards as required
Manage closeout of corrective actions associated with validation activities
Generates or approves Quality Risk Assessment documents in relation to executed
Ensure that the Change Control Procedure is implemented and maintained throughout the validation lifecycle
The Candidate Requirements
Bachelor’s degree in science or engineering related subject and a minimum of 8 years’ validation experience in the F&B, pharmaceutical, biopharmaceutical or medical device industry
Hands on validation experience with manufacturing equipment including tanks, Homogenizers, Pumps, sterilizers, parts washer, HVAC, controlled environmental chambers and utilities
Demonstrated proficiency and knowledge of CGMPs, industry validation practices, and change control practices
Right to live and work in Singapore (Singapore resident or citizen)
Demonstrated ability to effectively write technical documents, including test plans, protocols and reports
Excellent people management skills including collaboration and influencing with key stakeholders
Strong change management skills, experience of driving initiatives relating to cultural change
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