Validation Engineer

Location: Boyne City, MI

Time Type: Full time

Job Description

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Under broad supervision, assists in the fabrication, installation, operation, application, maintenance, and repair of mechanical machines, equipment, and tools. Inspects that all equipment is in accordance with the quality and safety standards. May require orientation in some phases of his work. Role typically requires between 3 and 5 years of experience.

FLSA Status
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Salary Exempt
Reports To
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Program Manager
Education / Experience
Required:
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BS in Mechanical or Bio-Medical Engineering Required
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Relevant qualifications in science, technology or engineering
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Experience / knowledge preference in Medical Device manufacturing, Contract manufacturing and / or Pharmaceutical / Bio-Pharmaceutical
Preferred:
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Experience in CNC machining processes
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Experience in any of the following: six sigma, lean manufacturing, process capability and statistics
Essential Functions, Knowledge and Competencies
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Excellent interpersonal skills
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Ability to lift 50 pounds
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Excellent communication skills both written and verbal
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Self-starter / team player / minimal supervision
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Excellent analytical and reporting capabilities
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Must be able to plan, organize, and implement multiple concurrent tasks
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Blueprint / Engineering schematic reading and interpretation
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Intermediate PC skills
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Medical Device experience with a high volume-manufacturing environment desirable
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Must be willing to work as part of a multi-site team and be able to travel as part of the job
Responsibility/Authority
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Conduct validation activities in compliance with Regulatory standards and requirements and Precision Edge Surgical procedures
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Develop validation documentation as required (e.g. plans, protocols, reports, procedures)
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Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.)
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Prioritize qualification activities in line with the project schedule
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Coordination, implementation and active participation in the site validation program for product, process, equipment, software, methods, utilities / facilities and cleaning
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Provide input into all project phases (i.e. from design through to the commissioning and qualification execution phases of the project)
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Assist in the evaluation of the validation statues of contract manufacturers and provide guidance where needed. Review and approval of documents prepared by the validation team, other departments and contractor organizations (e.g. commissioning test plans, impact assessments, change controls)
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Resolve and assist in the closure of deviations initiated during qualification / validation execution
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Initiate and implement change control activities in accordance with Precision Edge Surgical procedures
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Co-ordinate re-validation activities
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Generate procedures / other documentation as applicable
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Conduct training in validation methodologies and related procedures as required
Supervisory Responsibilities
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None

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.