- 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
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
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
