We are looking for a driven, talented Sr. Validation Engineer to join our team to support New Product Introduction (NPI) cross-functional efforts.
This individual will work in a dynamic team-oriented environment and has primary responsibility for defining, implementing and maintaining validation for manufacturing processes and systems. Ideal candidate must have a strong process development or process engineering background. As a Sr. Engineer, the ideal candidate is able to work independently requiring minimal direction.
Represent the Consumable Validation group in a cross functional NPI project teams, ensuring validation requirements and deliverables are communicated to the teams.
Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.
In collaboration with end users, process owners, Quality Engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems.
Write reports summarizing results and statistics for all equipment and process validation projects.
Be accountable for timely completion of all validation deliverables in accordance with project timelines.
Learn and understand the applicable technology and engage in technical discussions.
Provide consultation to other departments performing validation activities.
Provide input for creation of requirements documents.
Actively participate in creation of risk management documents such as pFMEA for systems and processes.
Perform job function in compliance with the internal procedures and applicable external regulations and standards, e.g. FDA QSR, ISO-13485.
Initiate and execute controlled document change requests.
Execute other related tasks assigned by the supervisor.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
A minimum of 7 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech).
Knowledge and working application of FDA and cGMP requirements.
Intermediate knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management.
Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable.
Knowledge and working application of standard operating procedures.
Demonstrated ability to accomplish goals in collaboration with cross-functional teams.
Demonstrated analytical problem solving skills.
Computer competency in MS Office.
Excellent interpersonal, written, and verbal communication skills.
Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically.
Requires a bachelor’s degree or master’s degree in engineering or science and a minimum of 7 years of related experience.
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