Senior Validation Quality Engineer
Millipore Corporation

Job Info

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You will be in responsible for developing and executing equipment and process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, and other key internal/external stakeholders ( R&D, Supply Chain, etc.). Experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet MilliporeSigma, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site and divisional quality goals and priorities. Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site. Primary

Responsibilities:

Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. Driving cost reduction projects and reviewing/analyzing/improving the effectiveness of quality improvement tools and programsLeads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Application Validation Plans.Leads the execution of Risk Management deliverables to ensure compliance to ISO 9001 and demonstrates a primary commitment to patient safety.Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, customer complaint investigations, and CAPA's.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls for product validation, process validation, and applicable validation activities.Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers. Coach and mentor new and junior members of the team.Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validationProactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance eventsLead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.Executing/supporting material qualification projects and leading/assisting with investigations related to raw materials/components.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls (CTQ, CQA, CPP) for product validation, process validation, and applicable validation activities.Review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes.Generate CTQ monitoring data for equipment and processes.Performing root cause analysis and corrective actions for process and equipment-related quality issuesProvides project direction, coaching, and mentoring for engineering and technical team personnel.Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.Supports internal and external regulatory audits.Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.Support development, implementation, and training of site quality initiatives.

Who you are:

Basic Qualifications7+ years validation experience handling of multiple projects within the biopharma, biotech or medical device industries.Minimum B.S. degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalentFull understanding of product, equipment and process validationDemonstrated capability of applying risk management concepts and toolsHands-on experience in troubleshooting and the application of quality system standardsExperienced at working in cross-functional teamsStrong written and verbal communication skills (internal/external)Strong teamwork and collaboration skillsExperience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processesExperienced with Quality & GxP IT compliance requirements

Preferred Qualifications:

ASQ Quality Engineer Certification (CQE)Six Sigma CertificationQuality by DesignApplied/industrial statistics experienceDetailed Knowledge of GMP, ISO and FDA design and development quality requirementsKnowledge of aseptic processing

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