Process Validation Specialist

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We are a fully-integrated, global contract manufacturer providing full-service medical device development and manufacturing for spine, reconstruction, sports medicine & trauma, and extremities markets.

Our disruptive renewed strategy allows us to provide true “Concept to Launch” support to OEM customers. We are able to assist our customers during all stages of their manufacturing journey, from device conception and manufacturing through to finishing and polishing, and eventual packaging.

Whatever you need – a single development or manufacturing step or a fully-integrated manufacturing service – we can help you realize your vision, simplify your supply chain, and shorten your overall lead time.

As the medical division of Lincotek Group, we have access to a lifetime’s experience of coating technologies and innovation, enabling us to support hundreds of OEMs globally in the development of dedicated processes to suit their needs.

With bases established in Europe, North America, and Asia, we support our customers wherever they may be located and be responsive to their demands.

For our site in Cadriano (BO) we're searching for a qualified and resourceful Process Validation Specialist.

PRIMARY FUNCTIONS

The primary function involves executing and reviewing process validations through IQ, OQ, PQ for machines and systems used in the production process of medical devices. Specifically, the resource will need to:

• Develop validation plans in coordination with plant management, engineering, production/operations, quality assurance and supply chain operations
• Analyze validation test data to determine whether systems or processes have met validation criteria
• Develop risk assessment for each validation process
• Work with all entities to study data and provide support to determine root causes of production problems
• Prepare, maintaine and review validation and compliance documentation
• Conduct validation or qualification tests of new or existing processes and equipment.
• Develop of tracking validation activities, test results, and validated systems.
• Manage all aspects of validation testing.
• Coordinate with all departments to develop new testing of products and processes.

• Collaborate with all departments and customer contacts to determine validation objectives and standards.

• Monitor processes, materials, operations, equipment, or events to detect or assess problems.

REQUIRED EDUCATION AND SKILLS:

• Master's degree in a technical-scientific field such as Chemistry, Industrial Chemistry, Biology, Engineering.
• 3-5 years of experience in a similar role.
• Knowledge of quality analytical tools including, but not limited to, SPC, FMEA, PFMEA.
• Experienced in the preparation of reports based on results of validation and qualification tests or reviews of procedures and protocols.
• Experienced in quality functions including ISO certifications and requirements, FDA regulations and Responsible to participate in audits and provide data, information, and resources to meet compliance needs.
• Effective communication skills with internal and external stakeholders regarding status, timing, and production issues impacting the project
• Ability to solve practical problems by providing flexible solutions in various aspects related to the activities performed.
• Knowledge of ISO 13485, ISO 10993, ISO 14971 standards.
• Proficiency in Microsoft Office package.
• Good knowledge of the English language.

Lincotek Surface Solutions provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.