Associate Validation Engineer
· We are seeking a Associate Validation Engineer who will be responsible for supporting the manufacturing business units, Engineering, R&D, Production, and QA/QC.
· This individual will design and perform validations for new and upgraded pharmaceutical manufacturing processes, and guide engineering project teams in application of quality and regulatory requirements to projects.
· In addition, will assist in research, develop and prepare specifications for improvements to existing and/or new products, processes, equipment, and technology.
· Also, will be held accountable for project initiation, planning, overseeing development, testing, implementation, and closeouts from start to finish.
Responsibilities:
· Prepares, executes, and finalizes protocols (IQ, OQ, PQ, PVP and PVR) for validating current, new and improved manufacturing processes and products under minimal direction.
· Documents, coordinates the execution, and summarize qualification activities.
· Maintains existing protocols to be prepare for third parties review upon request.
· Coordinates planning, organizing, integration and completion of engineering project within assigned responsibility.
· Coordinates maintenance and contract administration duties.
· Supports in design and executes validation plans and programs for new and improved dietary supplement equipment.
· Manages the qualification schedule for the project and ensures deliverables are met and documented per the project plan.
· Occasionally supervises specialized contract personnel and outside vendors in the performance of contract validation services.
· Represents the company as the point of contact with regulatory agencies, including interface with the inspectors.
· Evaluates existing equipment and processes, investigates and identifies new technology developments for ongoing improvements, including automation improvements, machine upgrades, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
· Provides technical input to Manufacturing, Quality and Reliability organizations for failure.
· Analysis, root cause and corrective action assessment, and technical training.
· Work with Production Supervisors to train production personnel on new equipment and processes.
· Works with consultant to optimize the current work load and process.
· Maintains working knowledge of current industry standards.
Qualifications:
· Min Bachelor Degree in Engineering or equivalent work experience and education.
· Direct experience with analyzing and evaluating methods of production to efficiently allocate resources (equipment and labor) including time studies and line balancing.
· Knowledge of U.S. FDA, cGMPs, and QSR.
· Excellent written and verbal communications skills, as well as detail oriented organizational skills.
· Ability to utilize basic computer software such as Microsoft Office, Excel, Power Point, Word, and Outlook.
· Adapt in fast pace work environment and able to deal with multiple critical task/issues.
· 5-7 years in Quality Engineering, Validation, Industrial Quality Control, and/or Quality Assurance.
· 0 - 3 years of work experience in dietary supplement, medical device, pharmaceutical or other regulated industry.
Interested candidates please send a copy of your resume to [email protected]
Email Subject: Validation Engineer – Leon
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
