Senior Validation Quality Engineer
Millipore Corporation

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.)Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site. This will be a hybrid role and it will be necessary to live within a reasonable commute of our site in Danvers, MA. Primary

Responsibilities:

Generate and execute validation protocols (Feasibility, OQ, PQ, PPQ) for various raw materials, fixtures and equipment'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.Perform and facilitate raw material change and new equipment risk assessments.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.Lead all validation involving design transfer of New Product Introduction Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validationLead in troubleshooting. Proactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance eventsLead in implementing change and improvement solutions across cross- functional teamsLead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.Lead by addressing lessons learned and reviewing complaint data in support of development, modification and improvement of design processes and quality management systemLead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.Perform and facilitate raw material change and new equipment risk assessments and validation.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.Lead in troubleshooting and Root Cause Analysis (RCA)

Who you are:

Minimum Qualifications:

5+ 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 RSRMS