Validation Engineer

Marmon Holdings, Inc.•Boyne City, MI

About The Position

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.

Requirements

BS in Mechanical or Bio-Medical Engineering Required
Relevant qualifications in science, technology or engineering
Experience / knowledge preference in Medical Device manufacturing, Contract manufacturing and / or Pharmaceutical / Bio-Pharmaceutical
Excellent interpersonal skills
Ability to lift 50 pounds
Excellent communication skills both written and verbal
Self-starter / team player / minimal supervision
Excellent analytical and reporting capabilities
Must be able to plan, organize, and implement multiple concurrent tasks
Blueprint / Engineering schematic reading and interpretation
Intermediate PC skills

Nice To Haves

Experience in CNC machining processes
Experience in any of the following: six sigma, lean manufacturing, process capability and statistics
Medical Device experience with a high volume-manufacturing environment desirable
Must be willing to work as part of a multi-site team and be able to travel as part of the job

Responsibilities

Conduct validation activities in compliance with Regulatory standards and requirements and Precision Edge Surgical procedures
Develop validation documentation as required (e.g. plans, protocols, reports, procedures)
Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.)
Prioritize qualification activities in line with the project schedule
Coordination, implementation and active participation in the site validation program for product, process, equipment, software, methods, utilities / facilities and cleaning
Provide input into all project phases (i.e. from design through to the commissioning and qualification execution phases of the project)
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)
Resolve and assist in the closure of deviations initiated during qualification / validation execution
Initiate and implement change control activities in accordance with Precision Edge Surgical procedures
Co-ordinate re-validation activities
Generate procedures / other documentation as applicable
Conduct training in validation methodologies and related procedures as required