Title:  Validation Technician

Job Summary

This role will support validation projects with key focus around customer specification, validation master plan, protocols, and reports. This person will provide the company with the technical and Validation resource to manage the Validation deliverables on selected projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.

Essential Duties and Responsibilities

• Support Automation, Tooling and Process Engineers with validation activities.
• Will be required to assist in preparing IQ, OQ and PQ protocols and reports.
• Raising and writing change control requests.
• Drafting change control proposals.
• Drafting project trackers.
• Aligning the required approvers.
• Managing customer approval.
• Writing validation technical reports.
• Chairing meetings and taking minutes.
• Co-ordinating project timelines across all automated lines.
• Aligning all the required resources for completion of a validation project.
• Other duties as assigned.

Additional Responsibilities

Education

• Education: Associate or Bachelor’s Degree in engineering or equivalent on the job experience in a technical discipline to include: manufacturing, industrial, materials or plastics
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

Work Experience

• Minimum 3 years 3 Years of experience in engineering related discipline required and
• Six Sigma and Lean Manufacturing experience required
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Preferred Knowledge, Skills and Abilities

• Good understanding and knowledge of validations in a Medical Device environment.
• Good understanding of computer system validation.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
• Must be able to prioritize and organize tasks.
• Must have excellent interpersonal & problem-solving skills & be able to interface with employees in all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Self-motivated and solution-oriented personality.
• Excellent written and verbal skills.
• Good communication, project management, and interpersonal skills.
• Good organizational skills.
• Effective problem-solving skills.
• Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
• Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws