Validation Engineer/Specialist

Job Description

• 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)
• Risk Management practices (i.e. Assessments, Functional Risk Documents, pFMEA, etc.)
• Equipment qualification and process validation
• Computerized System Validation (PLC, HMI, etc.)
• 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

Education:

• B.S. Engineering (e.g. Computer Science, Chemical, Mechanical, Electrical, etc.)

Minimum Skills:

• 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

Positions available for Puerto Rico.

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