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Process Engineer

Apex Systems

This is a Contract position in Pima County, AZ posted September 27, 2020.

Process Engineer (2) Large Medical Device Company is adding two Process Engineers to their team. Come expand your skills with a professional team while helping cancer patients. Beautiful campus with many amenities and great mountain views POSITION SUMMARY Participates on and leads validations and projects within the manufacturing areas. This engineer is responsible for successful project completion including necessary reports and approvals. Identifies and assists with implementing improvements around current manufacturing processes with guidance from manager and senior engineers. Responsibilities also include equipment and process validations as well as process characterization and root cause investigations. ESSENTIAL FUNCTIONS Assess existing processes and equipment and identify and implement improvements. Implement new or transferred manufacturing processes in a timely manner. Lead andor participate in equipment and process validations. Assist in troubleshooting of process andor equipment issues. Strong written and verbal communication skills. With guidance, able to prepare and present technical information and project summaries to peers and management. Monitors work to ensure quality and to continuously promote Quality First Time. Automation Factory Support specifics Assist in designing and implementing new equipment and tools to improve manufacturing efficiencies, reduce ergonomic stress, and improve quality. -Update, create and sustain Standard Work documents. -Create and update drawings using ProEngineer or SolidWorks. – Work as part of a project team in the development andor implementation of new equipment and tools. -Technical support for daily production issues related to manufacturing equipment. Quality Support specifics -Assist in addressing, owning, and resolving quality related issues for the manufacturing departments (ex CAPAs, and Audits) -Consistently uses company concepts, policies and procedures, familiar with and follows standard practices. -Executes experiments participates in experimental design. -Utilizes DOE where appropriate. -Analyzes data, evaluates results, forms conclusions and providesimplements process or document improvements. May perform other duties as required or assigned. Skills Knowledge, Skills and Abilities Must have the ability to manage priorities based on the needs of the manufacturing area with some guidance from the reporting manager and senior management. Knowledge of biomedicalbiotechnology manufacturing. Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought. Strong understanding of engineering principles and concepts. Strong computing skills utilizing Microsoft Office tools such as Excel, Word, and PowerPoint Strong teamwork skills. Demonstrated troubleshooting and problem solving skills including the use of designed experiments. Ability to meet project deadlines. Ability to multitask and prioritize with some guidance from management. Automation Factory Support specifics -Experience with automated manufacturing equipment and automation technologies. -Experience with CAD programs such as ProEngineer andor SolidWorks. -Experience in a regulated environment. Knowledge of FDA Quality System Regulations (QSR’s) is a plus. -Experience with Lean Systems. Quality Support specifics -Experience in reagent or instrument manufacturing for a Medical Device or Pharmaceutical company. -Experience in a regulated environment. Knowledge of FDA Quality System Regulations (QSRs). Education – Requires Bachelor degree in Science. – 4 years of relevant experience in a regulated industry – MS degree and 2 year’s relevant experience is also acceptable Please apply to for immediate consideration EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or