Basic Function and Scope of the Position :
This position provides technical leadership and execution of Process and Equipment Validations to satisfy quality and regulatory requirements for Consumables manufacturing in a rapid growth environment.
This position will also serve as a technical resource to improve product quality, reliability, and process capability.
Tasks and Responsibilities :
Develop and execute validation protocols for Consumables manufacturing equipment and methods used at all levels of consumable manufacturing
Perform late stage development, qualification and validation of consumables production methods
Analyze test results, draft validation / engineering reports and make technical recommendations
Participate in project management meetings as Validation representative determining validation requirements, as needed.
Provide technical input with respect to test method validation requirements, as needed
Learn and understand the applicable technology and engage in technical discussions.
Identify areas and opportunities to improve manufacturing facilities, processes and equipment.
Provide consultation to other departments performing validation activities
Ensure validation program meets requirements of FDA and ISO
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational Background :
BS / MS in Biochemistry, Molecular Biology, Chemistry, and related engineering field
Preferred Experiential Background :
Minimum 3 years of experience in qualification and validation or manufacturing processes and equipment
Minimum 3 years of technical writing in many of the following areas : validation protocols, validation reports, SOPs, engineering / development reports;
validation master plans
Must be an effector communicator, able to effectively work in a team environment and interface well with the organization
Expert user level experience with many of following techniques : Chromatography, HPLC, LCMS, UV / fluorescence spectroscopy, biochemical (enzyme) assays
Proficient knowledge and working application of process and equipment validation principles for regulated industries including : FDA cGMP;
ICH / USP guidelines ANSI / ISO / ASQC; FMEA, Risk Analysis and Design Controls
Experience with statistics, Statistical Process Control and DOE techniques is desired
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.