Validation Engineer

1w1 week ago

Marmon Holdings

US · Full-time · $95,000 – $125,000

About this role

As part of the global industrial organization Marmon Holdings—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. The role involves assisting in fabrication, installation, operation, maintenance, and repair of mechanical machines under broad supervision.

Conduct validation activities in compliance with regulatory standards and Precision Edge Surgical procedures. Develop validation documentation such as plans, protocols, reports, and procedures. Execute validation protocols including Equipment IQ/OQ, Process OQ, and Process PQ.

Prioritize qualification activities in line with project schedules and coordinate the site validation program for product, process, equipment, software, methods, utilities, facilities, and cleaning. Reports to Program Manager and works as part of a multi-site team. Must be willing to travel as part of the job.

Provide input into all project phases from design through commissioning and qualification execution. Assist in evaluating validation status of contract manufacturers and resolve deviations during qualification. Fosters a culture where everyone’s empowered to be their best with diverse learning opportunities.

Requirements

BS in Mechanical or Bio-Medical Engineering Required
Relevant qualifications in science, technology or engineering
Experience/knowledge in Medical Device manufacturing, Contract manufacturing and/or Pharmaceutical/Bio-Pharmaceutical preferred
Experience in CNC machining processes preferred
Experience in six sigma, lean manufacturing, process capability and statistics preferred
Blueprint/Engineering schematic reading and interpretation
Ability to lift 50 pounds
Must be willing to work as part of a multi-site team and be able to travel

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)
Prioritize qualification activities in line with the project schedule
Coordinate, implement and actively participate in the site validation program for product, process, equipment, software, methods, utilities/facilities and cleaning
Provide input into all project phases from design through to commissioning and qualification execution
Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed
Resolve and assist in the closure of deviations initiated during qualification/validation execution

Benefits

Part of global industrial organization Marmon Holdings backed by Berkshire Hathaway
Diverse learning and working opportunities
Culture where everyone’s empowered to be their best
Committed to making a positive impact on the world