Process Validation Engineer 1

Job Summary: Ofni Systems is an industry leader in automating the validation process. Our proprietary validation management tool, FastVal, allows us to perform validation projects in a fraction of the time of traditional MS Word template-based methods. 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 Process Validation Engineer to be on the cutting edge of validation techniques. This individual will assist in the creation of automation tools for process validations, determining system requirements, testing strategy, and creating validation deliverables. Our ideal candidates are experts on the requirements of 21 CFR 211.113 and 820.70, have excellent critical thinking and interpersonal skills, and are motivated to meet client needs for compliance.

Candidates must have:

• BS or equivalent degree in Biology, Chemistry, or other applicable Science or Math
• 2-5 years experience in process validation, preferably in FDA-regulated environments
• Familiarity with 21 CFR 211.113 and 820.70

Job Requirements will include:

• be willing to work collaboratively and in a client-focused environment
• be willing to learn Ofni Systems validation methodology for validation automation
• be highly motivated, organized, and able to manage priorities
• have the ability to build and retain client business
• have the highest standards for quality, accuracy, and professionalism
• have strong communication, presentation, and interpersonal skills

Responsibilities may change over time, so this is an ideal opportunity for a motivated and energetic individual.

Contact us about this job

Posted August 27, 2012, to be filled immediately. Multiple positions available.

Principles only. Recruiters, please do not contact. Please, no phone calls about this job.