Validation Engineer/Specialist (Atlanta, Georgia)

Validation & Engineering Group; Duluth (MN); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. is seeking a Validation Engineer/Specialist based in Duluth, Minnesota. The ideal candidate will have 3-5 years of hands-on experience in validation protocols, specifically within medical device manufacturing.

This full-time position involves planning and integrating commissioning and qualification activities, equipment qualification, and process validation. Strong technical writing and communication skills, alongside proficiency in Microsoft Office applications, are crucial for success in this role.

Qualifikationen

• 3-5 years hands-on validation experience in medical device manufacturing.
• Ability to work independently with project teams.
• Strong communication and technical writing skills.

Aufgaben

• Plan and integrate commissioning and qualification activities.
• Conduct equipment qualification and process validation.
• Assist in deviation investigation and resolution.

Kenntnisse

Risk Based Approach

Validation protocols

Technical writing

Microsoft Office

Interpersonal skills

Jobbeschreibung

Validation Engineer/Specialist (Atlanta, Georgia)

Full-time

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.

Responsibilities

• Expertise in “Risk Based Approach” for Commissioning and Qualification practices
• Planning and Integration of Commissioning and Qualification activities in medical device manufacturing (Class II preferred)
• Equipment qualification and process validation
• 21 CFR Part 11 requirements and how to incorporate these requirements into an efficient testing strategy
• Assist in deviation investigation and resolution for problems and issues encountered during field execution activities

Qualifications

• 3-5 years hands‑on validation experience (writing and execution of validation protocols)
• Capable of working independently with minimal supervision, and communicating with project team members to assure timelines are met
• Great technical writing and communication skills
• Proficiency in Microsoft Office application (Word, Excel and Project)
• Effective interpersonal and problem solving skills
• Demonstrate excellence in good documentation requirements and attention to detail

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.