Process Engineer II

Description The Process Engineer II is responsible for ensuring the organization is compliant with all applicable regulations and standards in the areas of process validations. In addition, this position leads process change and improvement throughout the different areas of the company, including manufacturing. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to the manufacturing floor. The Process Engineer II makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above. Requirements Duties and responsibilities Provide backup support to the Director Research and Development Operations, as needed. Perform critical review of Process Engineer I project plans and related documents to ensure implementation is accurate and timely. Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against plan. Perform data and technical presentation reviews as needed. Understand and apply the applicable regulations and standards for equipment qualification and process validation to ensure compliance. Statistical and analytical methods to understand processes. Use LEAN Manufacturing principles to analyze and make recommendations for process optimization and implementation. Work with other department heads or designees on projects as delineated on project plans to ensure timely completion of projects. Develop equipment and process validation protocols (IQ, OQ, PQ) and reports as needed. Lead and perform equipment qualifications and process validations as needed. Develop and monitor process and equipment metrics to use for optimization analysis. Develop and implement solutions with minimal supervision. Comply with FDA and AATB tissue banking standards. Other duties as assigned. Qualifications BS in Biomedical, Mechanical, Industrial Engineering or other applicable engineering discipline. Advanced degree (Master's) a plus. A minimum of 3 years of experience in Tissue Banking, Device, Biologics, or pharmaceutical industry in a relevant engineering role. Leadership experience preferred. Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills. Ability to effectively communicate with multidisciplinary teams. Excellent technical skills and writing. Strong knowledge of LEAN manufacturing principles preferred. Strong knowledge of 21CFR 1271 regulations and AATB guidelines. Highly proficient in project planning software. Microsoft Project preferred. CTBS certified (or certified within two years of employment). Strong work ethics. Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship Working conditions Job requires working in office. Must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. Physical requirements Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing engineering plans. Direct reports Intern Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training. Vivex Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.