Validation Engineer - Puerto Rico South Area
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Description
Engineer 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.