Cleaning Validation Engineer – Risk-Based CQ & 21 CFR 11

Validation & Engineering Group; Duluth (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group in Duluth, Minnesota is seeking a qualified Validation Engineer to provide solutions in the Pharmaceuticals and Medical Devices industries. The role involves expertise in Cleaning Validation and a Risk Based Approach, with responsibilities including planning and managing Commissioning and Qualification activities.

A successful candidate will possess 3-5 years of hands-on validation experience, excellent technical writing skills, and proficiency in Microsoft Office applications. Join a company dedicated to innovation and quality in the field.

Qualifications

• 3-5 years hands-on validation experience, including writing and executing validation protocols.
• Ability to work independently with minimal supervision.
• Great technical writing and communication skills.

Responsibilities

• Perform Cleaning Validation and Risk Based Approach practices.
• Plan and integrate Commissioning and Qualification activities in medical device manufacturing.
• Assist in deviation investigation and resolution.

Skills

Cleaning Validation

Risk Based Approach

Technical Writing

Microsoft Office

Interpersonal Skills

Job description

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.

Job Description

• Cleaning Validation is a must
• 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

Additional Information

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

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply

Job Location