Computer Systems Validation Engineer
Ofni Systems is a growing, dynamic company providing a full range of 21 CFR 11 and Annex 11 compliance services. Our clients include the FDA, Fortune 500 pharmaceutical manufacturers, clinical research organizations, medical device manufacturers, and a range of large and small FDA-regulated companies.
We are hiring a Validation Engineer to be on the cutting edge of automated validation techniques. You will be responsible for implementing our validation solutions while working with industry-leading companies. Ideal candidates are experts on the requirements of 21 CFR 11, have excellent critical thinking and interpersonal skills, and are motivated to meet client needs for compliance. If you are an A-level engineer who enjoys the challenge of solving real-world compliance problems then we would like to talk with you.
Candidates must have
- BS or equivalent degree in math, science or engineering
- At least one year experience in software testing, preferably in FDA-regulated environments
- Familiarity with 21 CFR 11 and Annex 11
Job Requirements will include
- Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Identify and qualify all computer systems which impact cGMP operations using a risk based methodology
- Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execution of validation plans and validation documents
- Work with overall project manager to include validation activities in implementation timelines
- Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Able to work collaboratively and in a client focused environment
- Be highly motivated, organized, and able to manage priorities
- Have the ability to work with multiple clients and projects
- Have the highest standards for quality, accuracy, and professionalism
- Have excellent communication, presentation, and interpersonal skills
This is an ideal opportunity for motivated and energetic individuals who want to advance their skills and move their career forward.
To be filled immediately. Multiple positions available.
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