Sr Validation Engineer, Agile PLM

CSV/Assurance Support SpecialistThis individual will provide CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality. As part of IT Quality and Compliance organizations. Work closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures. Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary manage contract resources to generate and or execute validation documents and activities.Job Responsibilities:Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriateInitiates, leads and authors cGMP risk assessment, gap analysis, and deviation management associated with validation programs with precise document writing following Good Documentation Practices (GDocP) with clarity to meet the set forth expectationsEnsure Validation Plans and strategies are in alignment with validation policies, procedures and guidelines and external regulatory requirements, and European and International standardsInteract with QA, IT, Engineering and business area users to understand functionality and use of automated control systemsReview and provide feedback to plant and corporate policy writers on CSV guidelines, specifications and policiesCoordinate tasks with validation technician(s) and validation consultants to provide project and technical direction, as neededMust be able to manage complex projects, set/achieve timelines, direct/redirect resources and manage assigned fundingPlan and lead revalidation of computer systemsOwn tasks related to periodic reviews, and remediation activities on validated systems. Plans and/or executes these validation protocolsParticipate on investigation teams in the event of adverse validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skillsWrite or assist with the writing of Standard Operating Procedures, Business/Software Requirements and Validation Master PlansMust maintain a thorough working knowledge of the ICU Medical Systems and Validation requirementsMust be able to work extended schedules as required to meet deadlinesPerform other related duties as assigned or requiredKnowledge, Skills & Qualifications:Must have experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11 and 21 CFR Part 11 Electronic Records and Electronic SignaturesWorking knowledge of Oracle Agile PLM, Oracle EBS is requiredWorking knowledge of data migration, sampling methodsExperience in one of the following disciplines is required: Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications and/or Controls systems/softwareMust have good organizational, presentation, meeting facilitation and technical writing skillsRequires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving and resolving problems, make recommendations when less than complete information is provided, and finding ways to accomplish goals through innovative planningA high level of attention to details and the ability to proofread and audit validation documents is requiredEducation and ExperienceRequires a BA/BS in a Computer Science, Information Systems, or other related field in sciences. Masters’ degree is preferred.8+ years' experience in IT analysis, design and implementation including 2+ yrs with Oracle Agile PLM or similar QMS systemMin 3 years direct experience of computer systems validation/assuranceMasters’ degree is acceptable in lieu of 2 years of experienceRequires strong, demonstrable knowledge of :Multiple SDLC development process (Scrum, XP, Kanban, etc.)Experience with 3rd party vendor integrationsTravel RequirementsTypically requires travel less than 5% of the timePhysical Requirements and Work EnvironmentThis is largely a sedentary role.This job operates in a professional office environment and routinely uses standard office equipment.Required Skills: 1) Agile PLM 2) Oracle EBS - client side experience (not consulting) 3) Experience in lifesciences, manufacturing, or similar regulated industry 4) Testing experience Looking for a PLM implementation consultant, with a lot of testing experience. Could also be an Agile PLM business systems analyst with hands on testing, coupled with life science industry/ manufacturing experience. Note - projected as a 6 month+ contract to hire Candidates can sit remote, but might need to travel to ICU location in Southern California a few times a year.