Job TitleEngineer for equipment and process validation including IQ, OQ, TMV/MSA, PQ protocol generation and execution.Will be hands-on with automation, tooling, and maintenance technicians to coordinate and follow-up on equipment troubleshooting, repairs or service required to assure that equipment validation is successful and for resolution of any deviation. Leads or leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies. Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Manages the development and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project's key stakeholders. Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems other duties may be assigned.Requirements: Minimum 2 years in validation in the regulated industry. Project & Time Management Skills.
Experience in equipment validations protocol generation, execution and report. Good time management skills to comply with timeline. Bachelor Degree in Engineering completed. Bilingual. Willing to work full On-Site.