Validation Engineer

Validation Engineer Angola, IN 46703 From $70,000 a year - Full-time From $70,000 a year - Full-time Validation Engineer Salary Position Job is located in Boyne City, MI or Angola, IN Kingfisher Recruiting has been hired by one of our top clients to source a Validation Engineer for their Boyne City or Angola locations. This position is responsible for supporting and executing validation activities in compliance with regulatory standards, internal procedures, and project requirements. The role includes developing and executing validation documentation such as plans, protocols, reports, procedures, Equipment IQ/OQ, Process OQ, and Process PQ documentation. The Validation Engineer will coordinate and participate in validation programs for products, processes, equipment, software, methods, utilities, facilities, and cleaning activities, while supporting all project phases from design through commissioning and qualification.

Education / Experience

Required Bachelor's degree in Mechanical Engineering or Biomedical Engineering required Relevant qualifications in science, technology, or engineering Experience or knowledge in medical device manufacturing, contract manufacturing, pharmaceutical, or biopharmaceutical environments preferred CNC machining process experience preferred Experience with Six Sigma, lean manufacturing, process capability, and statistics preferred Essential Skills and Competencies Excellent interpersonal skills Strong written and verbal communication skills Self-starter and team player with ability to work with minimal supervision Excellent analytical and reporting capabilities Ability to plan, organize, and manage multiple concurrent tasks Blueprint and engineering schematic reading and interpretation Intermediate PC skills Medical device experience in a high-volume manufacturing environment desirable Willingness to work as part of a multi-site team and travel as required Ability to lift up to 50 pounds Responsibilities / Authority Conduct validation activities in compliance with regulatory standards and internal procedures Develop validation documentation including plans, protocols, reports, and procedures Execute validation protocols, including Equipment IQ/OQ, Process OQ, and Process PQ Prioritize qualification activities in alignment with project schedules Coordinate, implement, and actively participate in validation programs for product, process, equipment, software, methods, utilities, facilities, and cleaning Provide input through all project phases, from design through commissioning and qualification execution Assist in evaluating the validation status of contract manufacturers and provide guidance as needed Review and approve documents prepared by validation team members, other departments, and contractors, including commissioning test plans, impact assessments, and change controls Resolve and assist in closing deviations initiated during qualification and validation execution Initiate and implement change control activities according to internal procedures Coordinate re-validation activities Generate procedures and other documentation as applicable Conduct training on validation methodologies and related procedures as required Benefits Health Insurance on Day 1 Dental/Vision 401k Match PTO Plenty of opportunity for upward mobility at a stable and growing company

Pay:

From $70,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person