Senior Validation Engineer

Job Description

Job Senior Validation Engineer Location Milwaukee WI Lead Projects Inspire Teams Build What MattersWe serve pharmaceutical companies across the United States offering a vast array of services that assist companies with exceeding their goals and objectives In todays world its never been more important to understand regulations and quality assurance activities as they relate to operations vendors engineering construction and contractors In 2020 Compli LLC became a wholly owned subsidiary of George Butler Associates Inc This acquisition allowed Compli LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in house services Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma biotech API Medical Device and laboratory facilities Compli differentiates itself through an integrated approach to engineering construction commissioning and validation Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma biotech API Medical Device and laboratory facilities We are seeking an experienced SeniorProject Lead Validation Engineer to join our growing team Compli differentiates itself through an integrated approach to engineering construction commissioning and validation Summary The Senior Validation Engineer is responsible for providing technical leadership and engineering expertise in the commissioning qualification and validation of facilities utilities equipment systems cleaning processes and manufacturing processes within regulated life sciences environments What Youll DoLead and support commissioning qualification and validation activities for facilities utilities equipment systems cleaning and manufacturing processesDevelop and execute commissioning and validation lifecycle documentation including validation plans protocols test scripts reports and supporting documentationDevelop project specific commissioning qualification and validation strategies based on system requirements risk intended use and regulatory expectationsProvide technical leadership throughout all phases of projects including greenfield construction facility renovations equipment installation new product development product launch and process or system upgradesLead and perform system equipment and process risk assessments and technical analysesReview engineering and system documentation to ensure alignment with validation requirements and regulatory expectationsDevelop review and execute applicable system lifecycle deliverables including URS SRS FRS DDS RTM FAT SAT IQ OQ PQ and Final Validation Summary ReportsAuthor and review validation and qualification protocols technical reports operating procedures and other controlled documentationInvestigate and resolve validation discrepancies deviations and technical issues using sound engineering judgment and practical problem solving approachesSchedule and coordinate protocol execution with manufacturing facilities engineering quality project management contractors and other project stakeholdersManage multiple validation projects and priorities while meeting established project milestones and deadlinesProvide technical guidance and mentorship to validation specialists engineers and other project team members as appropriateServe as a technical resource and Subject Matter Expert SME in one or more areas of validation qualification or regulatory complianceInterface confidently and professionally with clients contractors management regulatory and quality personnel and project teamsSupport continuous improvement of validation practices standards templates and execution strategiesOther duties as assignedWhat Youll BringBachelors degree in a related life sciences or requisite industry training and experience5 10 years GMP experienceAbility to converse about scientific mattersAbility to work independently or in collaboration with othersIn depth understanding and application of validation principles concepts practices and standardsConsidered a Subject Matter Expert SME in one area of validationProficient in current Good Manufacturing Practices and other applicable regulationsExperienced with all pertinent industry best practices eg ISPE including development and execution of all applicable system life cycle deliverables eg URS SRS FRS DDS RTM Unit Integration User Acceptance testing FAT SAT Validation Planning IQ OQ PQ Final Validation Summary ReportDemonstrated expertise in at least one aspect of system qualification and regulatory compliance eg EMEA GCP GLP GMP QSR and internal requirements employing regulatory guidance and industry standardsExcellent written communication skills with emphasis in technical writingProficient in Microsoft Word Excel Power Point and ProjectPhysical Requirements \& Work EnvironmentAbility to work on a computer for extended periodsAbility to sit stand and walk project sites for prolonged periodsMust be able to travel to job sites occasionally minimum once per monthWhy Youll Love Working HereAt Compli youll work alongside talented professionals who share your passion for building great things We offer a people first culture and a comprehensive benefits package designed to support you personally and professionally including Medical dental and vision insuranceLife accident and disability coverage401k with company matchEmployee Assistance Program EAP and wellness initiativesPaid company holidays floating holidays and flexible time offProfessional development and career advancement opportunitiesJoin Our TeamIf youre ready to work on complex projects and build a career with impact wed love to hear from you Apply today and grow your future with Compli At GBA we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age race religion color sex national origin marital status genetic information sexual orientation gender identity gender expression disability veteran status pregnancy status or any other status protected by law