KR
Validation Engineer
Accepting applicationsKingfisher Recruiting · Angola, IN
Full-Time Associate aiarmategan
Posted
2d ago
Category
Test
Experience
Associate
Country
United States
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
This job description outlines primary duties, qualifications, and scope of the role, but does not limit the employee to only the work identified. Employees are expected to contribute wherever necessary to support the success of the company. This job description may be revised at any time and does not constitute a contract for employment or alter the at-will status of employment.
Show more Show less
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
This job description outlines primary duties, qualifications, and scope of the role, but does not limit the employee to only the work identified. Employees are expected to contribute wherever necessary to support the success of the company. This job description may be revised at any time and does not constitute a contract for employment or alter the at-will status of employment.
Show more Show less