Mark Arsenault Email and Phone Number
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I am interested in helping bridge the gap between technology and people. I enjoy and am skilled at combining engineering and scientific knowledge with human elements to collaborate with a variety of stakeholders.
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Senior Process EngineerGenentech Sep 2024 - PresentHillsboro, Oregon, United States-Develop, test, and qualify product-specific recipes for automated inspection machines at an evolving parenteral drug manufacturing facility, in keeping with the latest cGMPs and company-specific requirements-Drive process improvements and elevate decision-making as process engineering representative on Inspection Process Team-Enable critical quality decisions for commercial batches through technical assessments and subject matter expertise-Create and revise procedures and technical documents for a range of audiences having different levels of background knowledge and expertise-Communicate project outcomes and points of alignment across multiple levels of the organization-Drive to understand the "why" behind processes, requirements, and stakeholder concerns with the goal of making better decisions that benefit all parties -
Process EngineerGenentech Aug 2020 - Aug 2024Hillsboro, Oregon, United States-Developed, tested, and qualified product-specific recipes for automated inspection machines at an evolving parenteral drug manufacturing facility, in keeping with the latest cGMPs and company-specific requirements-Took on new role as process engineering representative of Inspection Process Team and quickly integrated as a core contributor-Created and revised procedures and technical documents for a range of audiences having different levels of background knowledge and expertise-Led the technical implementation and change management of automated inspection capability for a new product configuration-Communicated project outcomes and points of alignment across multiple levels of the organization-Designed and executed a study to determine the worst-case time needed for a drug product to reach ambient temperatures under multiple conditions, which included developing an empirical model and resulted in minimal changes to the existing manufacturing process-Drove to understand the "why" behind processes, requirements, and stakeholder concerns with the goal of making better decisions that benefit all parties -
Quality Engineer (Rotation)Genentech Jan 2023 - Jan 2024Hillsboro, Oregon, United States-Operated entire year as Quality Engineer on rotation, supporting a key product tech transfer, new equipment qualification/existing equipment requalification, and compliance-driven process changes-Reviewed and approved quality-critical test protocols, technical and validation reports, and associated deviations-Applied validation and engineering experience to provide an immediate and influential impact supporting sterilization, cleaning, and exception management requiring minimal outside coaching-Drove increased clarity, accuracy, and overall quality of high-visibility documents -Developed depth and breadth of knowledge in many new technical subject areas of the site, including process development and validation, filter integrity testing (FIT), Manufacturing Execution System (MES), and materials of construction (MoC) requirements for new process components -
Validation EngineerGenentech Apr 2019 - Aug 2020Hillsboro, Oregon, United States-Maintained compliance and operational state of critical equipment through regular and time-sensitive re-qualifications -Troubleshot and collaborated to resolve root causes of protocol deviations as they arose-Leveraged inspection and rotation experience to contribute meaningfully to validation executions early in job tenure-Earned reputation from stakeholders, especially manufacturing, as an effective and proactive cross-functional collaborator -Gained foundational process knowledge for nearly every operational area on site, developing more holistic end-to-end understanding -
Inspection TechnicianGenentech Aug 2015 - Apr 2019Hillsboro, Or• Upheld quality, safety, and regulatory standards of life-saving parenteral drugs as part of the final process check before patient use• Liaised between multiple departments and functional levels to drive greater mutual understanding• Presented error-reduction model to senior leadership as part of initiative to proactively improve compliance and reduce waste• Led daily coordination, decision making, and interdepartmental communication for 6 month period• Defended inspection process to regulatory agency, demonstrating depth of knowledge and confidence in procedures as face of the organization• Grew into go-to person for non-standard tasks and developed reputation for being able to quickly grasp complex concepts and communicate them to others• Guided process improvement team from ambiguous state to structured and focused agenda -
Validation Engineer (Rotation)Genentech Jan 2018 - May 2018Hiillsboro, OregonI executed and helped make technical and schedule decisions for a new tool project. The role required rapid learning, cross-functional communication, and a clear understanding of priorities.• Developed strategy for and executed high-visibility sampling tool project. Resulting annual savings projected to be $3m and 800 man-hours, along with reducing a known safety risk.• Reported out project impact and methodology to department leaders and stakeholders• Pioneered JMP software use in the department via statistically-based design of experiments strategy and data visualization• Navigated competing opinions about project risk controls from different SMEs to forge alignment• Supported and took partial ownership of time-sensitive documentation approval through rapid organization and communication with stakeholders while having little prior subject knowledge -
Undergraduate Research Assistant - Electrochemistry LaboratoryOregon State University Oct 2014 - Jun 2015Corvallis, Oregon• Investigated microscopic phenomena in microbial environments using groundbreaking electrochemical techniques• Led project to develop novel glucose sensor, to be presented to industry experts and the public• Performed sensitive experiments on micrometer scale using limited-availability reagents• Communicated experimental outcomes to research group containing graduate and post-doc chemistry experts and incorporate feedback to future experiments -
Undergraduate Teaching AssistantOregon State University Sep 2013 - Jun 2014Corvallis, Oregon• Reinforcement to students of fundamental physics concepts• Guided students through multi-step problems starting with basic laws• Planned weekly curricular activities and provided feedback for learning improvement• Proctored 1.5-2 hour exams with 100 students• Scored and recorded exam grades of 200+ students
Mark Arsenault Skills
Mark Arsenault Education Details
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Bioengineering And Biomedical Engineering
Frequently Asked Questions about Mark Arsenault
What company does Mark Arsenault work for?
Mark Arsenault works for Genentech
What is Mark Arsenault's role at the current company?
Mark Arsenault's current role is Senior Process Engineer at Genentech.
What is Mark Arsenault's email address?
Mark Arsenault's email address is ar****@****ene.com
What is Mark Arsenault's direct phone number?
Mark Arsenault's direct phone number is +154128*****
What schools did Mark Arsenault attend?
Mark Arsenault attended Oregon State University.
What are some of Mark Arsenault's interests?
Mark Arsenault has interest in Science And Technology, Environment, Health.
What skills is Mark Arsenault known for?
Mark Arsenault has skills like Interpersonal Communication, Product Development, Explaining Concepts, Emerging Trends, Conceptual Ability, Project Management, Teamwork, Engineering, Biologics, Medical Devices, Gmp, Agile And Waterfall Methodologies.
Who are Mark Arsenault's colleagues?
Mark Arsenault's colleagues are Alexander Diaz, Learning Premium Launchpad, Luke Cable, Jay Paul Singh, Dongping He, Cassie Vickers, Margit Bode.
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