VALIDATION ENGINEER

Nanosphere is a privately-held biotechnology company that optimizes the power of nanotechnology to set a new global standard for molecular diagnostics. We are a dynamic and growing organization that seeks dedicated individuals committed to aggressive growth, scientific leadership and an entrepreneurial spirit. In return, Nanosphere offers an exciting environment with competitive benefits and an attractive compensation package that will allow our employees to share in the growth and value of the Company.
We are seeking a Validation Engineer to write validation plans and to drive completion of all manufacturing validation efforts.
Responsibilities:
-Work with key management personnel to develop a process and cleaning validation strategy
-Write and revise validation plans, protocols and reports
-Drive completion of Installation, Operation and Process qualification of manufacturing equipment
-Implement and drive completion of process and cleaning validations
-Schedule and lead validation activities with assistance from manufacturing personnel
-Assist and guide manufacturing personnel in execution of protocols
-Use appropriate statistical tools for development of validation protocols
-Evaluate changes to manufacturing equipment and processes for impact to validation requirements
REQUIREMENTS
Requirements:
BS or MS in Engineering or Chemistry with minimum of 8 years of validation experience preferably in the medical device field. Demonstration of leadership capabilities required; ability to lead and drive completion of activities in a matrix environmentPrefer experience in process validation of in-vitro diagnostic productsKnowledge of FDA Regulation 21 CFR (Part 820, Part 11 etc) and GuidelinesWorking knowledge of chemical processing, manufacturing equipment, and plant utilitiesExperience in writing GMP/QSR validation plans, protocols and reports.Familiar with GAMP methodologyFamiliar with Software Development Life Cycle (SDLC)
The successful candidate will be a hands-on person who is willing to show extended effort to assure completion of activities on tight schedules. will be well versed and knowledgeable in medical device validation having extensive experience with statistical tools for validation.
For all candidates, we require excellent communication skills, flexibility and a strong team orientation. Candidates must hold current eligibility for employment in the United States.Qualified candidates may email resumes to [Click here for email]. Please reference job title “Validation Engineer” in the subject line of the email. EEO.