Process Validation & Test Engineer

SUMMARY The ideal candidate will use industry’s best practices and their expertise in regulatory requirements to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturing. We are looking for a highly motivated candidate, who can work cross-functionally to execute to the validation plan as well as material qualifications that come up as required.

RESPONSIBILITIES Lead nonconformance investigations and drive CAPA using structured RCA (e.g., 5-Why, fishbone, fault tree) and Lean Six Sigma tools. Plan and execute Material and process qualifications, spreadsheet validations Support Instrument (Medical Diagnostics Device) manufacturing and troubleshoot process related issues Initiate engineering change control Represent the process & validation group in cross functional meetings. Establish validation standards, support equipment/software/process requirements, develop V&V test protocols, lead pFMEA generation and effectively document results through the validation report. Qualify test methods fixtures to be able to test new/alternate components or troubleshoot issues. Coordinate with vendors/suppliers to create validation/material qualification requirements, review, and approve final reports. Create and maintain project timelines for validations/material qualifications that include risk mitigations to achieve required timelines. Recognizes need for and embraces concept of continuous improvement. Creates new ideas and recommendations based on engineering data, facts, and observations. Collects process data and performs trending and statistical evaluation to monitor process performance to understand stability and areas for improvement. Implement changes including initiating change control, performing impact assessment and evaluating risk for non-conformances or process improvements. Ability to identify root cause of failures or deviations to plan and come up with corrective actions. Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company. Strong ability to do root-cause problem solving, and implementation of effective preventative action. Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.

Bachelor's Degree in BioEngineering / Chemistry or related fields with 3+ years of experience in a manufacturing environment Experience in regulated industries (Food and Drug Administration, USDA) is required. Experience with software validation is a plus. TECHNICAL SKILLS REQUIREMENTS Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries. Candidates must possess flexibility and agility to respond to constantly changing conditions and priorities. Must be willing to quickly learn and become proficient in common systems used to manage the business - to include production schedule, quality deviations, ERP system(SAP preferred), and change control. Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software Work Environment: This position requires on site presence in a manufacturing environment. Physical requirements include the ability to lift up to 50 pounds, stand or walk for extended periods, and work in areas with moving mechanical parts and varying noise levels. Personal protective equipment (PPE) is required in accordance with facility safety protocols, which may include safety glasses, hearing protection, steel-toed footwear, and other equipment as designated by area-specific requirements. The U.S. base salary range for this full-time position is $77,000 to $118,000. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by