Pay Rate $32-$40/hr6-12 Month contract with right to hire1 openingThe Commissioning, Qualification, and Validation Engineer, Engineer II and Senior Engineer report directly to the Team Leader, Manager, or Director of the CQV Team, depending on the organizational structure. These positions are exempt. Up to 100% travel may be required.Expectations:The CQV Engineer and Engineer II performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments, authors protocols, initiates controlled documentation, and provides client support for CQV projects either independently or as part of a larger team. Responsibilities may include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports. The position requires extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements. CQV Engineers take a proactive role in supporting CQV projects and in providing client support. They build a high level of trust with internal and client personnel. This trust is developed through consistently upholding PCI Values and demonstrating Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).Responsibilities/Assignments:CQV EngineerPerforms commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the Sr CQV Specialist's, CQV Engineer II’s or Senior CQV Engineer’s direct or indirect supervisionAuthors protocolsInitiates controlled documentation in support of CQV projects as part of a teamDevelops documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports under the Sr CQV Specialist's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervisionInteracts with clients to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision from the Sr CQV Specialist, CQV Engineer II or Sr CQV EngineerFollows project planning, management and execution schedulesReviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended useInvestigates failures and deviations; creates reportsAnalyses and reviews spare parts lists to ensure they are fit for purposeReviews engineering drawings for accuracy and acts to correct errors under direct or indirect supervision of the CQV Engineer or Sr. CQV EngineerPerforms system walk-downs and makes changes using the change control of processesAssists with Corrective and Preventative Actions (CAPAs) and makes recommendations to resolve deficiencies under supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV EngineerCreates summary and analyses reportsCreates and maintains job plans, maintenance schedules and PMs under direct or indirect supervision of the Sr. CQV Specialist, CQV Engineer II or Sr. CQV EngineerUnderstands scope change and identifies scope change to supervisors for resolutionSkills Required:CQV EngineerClear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operationsUnderstands and is able to apply principles of commissioning and qualification with an eagerness to learnGood analytical, organizational, time management and problem-solving skills. Can develop problem statements, identify root causes and create corrective actions to be executed within a prescribed timeline under direct or indirect supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV EngineerGood writing skills. Able to develop and execute DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines under direct or indirect supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV EngineerBasic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirementsAbility to read and interpret P&IDs and identify boundariesWorking knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processesProficient with Microsoft Word, Excel, PowerPoint, Visio and ProjectHands-on experience working as a productive and supportive member of a project teamPossesses validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000, Ellab E-Val Pro or other validators and various temperature and relative humidity loggersDetail oriented. Completes work tasks and documentation with minimal errorsAbility to work independently or on a teamExperience & Education Required for CQV Engineer: BS in Engineering, one year of relevant project experience and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and Life Science manufacture industry experience is required. OrMS in Engineering, one year of relevant project experience and two years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and Life Science manufacture industry experience is required.If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson WellsManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. 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