Sr. Validation Project Lead - Medical Device

Job: Sr. Validation Project Lead - Medical DeviceLocation: Richmond, VA or Baltimore, MDCompli, LLC, a George Butler Associates’ affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry.We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, it’s never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction and contractors, which is why clients trust the Compli team.What You'll DoSupport Client commissioning / validation for facility, utility, equipment and systems validation projectsPrepare and execute commissioning / validation lifecycle documentsParticipate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgradeWrite summary reports for validation and qualification protocolsSupport project milestones, priorities and deadlinesProvide project reporting (e.g, budget, status and schedule reports)Write operating procedures for technical equipment and practices and proceduresPerform system and process risk assessments and analysesSchedule and coordinate protocol execution with other departments including manufacturing, facilities and project managementDevelop project specific validation plans and strategyAble to manage and execute multiple projects to meet client’s prioritiesProvide a practical approach to problem solvingIndividuals must represent Compli at client sites and interact confidently with clients, contractors, management and peersOther duties as assigned.What You'll Bring:Must have minimum 7 years CQV experience with aseptic liquid fill critical utilities (WFI, Clean Steam, Clean Compressed Air, etc.) capital projects.Bachelor’s degree in a related life sciences or requisite industry training and 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 (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., 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 (e.g., 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 ProjectTravel: Local personnel preferred.This role is not open to C2C staffing.It’s more than just a job…At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.At Compli, 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.