OverviewJob Title: Engineer Facilities & Manufacturing Operations (JP11989)Location: Thousand Oaks, CA. 91320Business Unit: F&E Drug Substance SupplyEmployment Type: ContractDuration: 4+ months (with possible extensions)Rate: $36 - $41/hour W2Posting Date: 11/13/2023Notes: Only qualified candidates need apply. Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.3 Key Consulting is recruiting an Engineer Facilities & Manufacturing Operations for a consulting engagement with our direct client, a leading global biotechnology company.Job DescriptionThis engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.Top Must Have Skill SetsEngineering and technical background (process equipment, troubleshooting, data-driven tech skills)Teamwork experienceProject improvement backgroundDay to Day ResponsibilitiesBe individually accountable for the verification deliverablesAssist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.Assist in development and review of User Requirements Specifications (URS).Suggest design modifications to address risks and design in quality and safety.Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeoutEnsure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.Ensure safety during commissioning, validation, maintenance and manufacturing activitiesReview and approve the commissioning report and ensure that all verification exceptions have been adequately addressedSupport Manufacturing and QA with Performance Qualification (PQ) activities if applicable.Related Activities:Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.Provide ad hoc technical support and guidance for manufacturing and maintenanceProvide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verificationAssist in developing and maintaining metricsProvide concise and clear documentation for actions taken on systemsOversee equipment vendors and contractors.Basic QualificationsMaster's degree ORBachelor's degree & 2 years of engineering and/or manufacturing experience ORAssociate's degree & 6 years of engineering and/or manufacturing experience ORHigh school diploma / GED & 8 years of engineering and/or manufacturing experiencePreferred QualificationsBachelor's degree in engineering-related field5+ years of relevant work experience with 3+ years' experience in operations/manufacturing environmentDirect experience with regulated environments (FDA, OSHA, EPA, etc.)Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipmentExperience implementing risk-based verification on major process equipment / automation projects, including validation protocol development and executionProcess equipment knowledge – cell culture, fermentation, purification, filling, and packagingProcess automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verificationKnowledge of Delta V, Rockwell, and Plant Information Systems is a plusDemonstrated strong communication and technical writing skillsStrengths in facilitation and collaboration / networkingExperience in developing SOPs and delivering trainingIndividual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-makingProven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)Problem solving and applied engineering.Basic technical report writing and presentationsVerbal communicationPersonal OrganizationDealing with and managing changeTechnical (Equipment Specific)Analytical Problem SolvingComputer Literacy (Maximo, TrackWise, E-Builder, PCS, BMS and QEMS)Specialized equipment/process expertiseAbility to handle multiple projects at the same timeSchedule development, Facilitation and collaborationBasic project management, project completion and follow-upProblem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.Negotiation, persuasion and facilitation CollaborationProject Cost developmentConflict ResolutionCustomer service in a technical settingManagement of contractors and vendors.Flexibility to work off-hours and fully on-siteWhy is the Position Open?Supplement additional workload on team.Interview ProcessWebEx interview with a panel of 1:-3 (potentially).We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.#J-18808-Ljbffr