Engineer, Biotech Equipment and Facilities

Engineer, Biotech Equipment and Facilities3 Key Consulting is recruiting an Engineer, Biotech Equipment and Facilities for a consulting engagement with our direct client, a leading global biotechnology company.Job Description:This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client in Thousand Oaks. The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy. The Engineer role will provide direct engineering technical support as follows:Model leadership behaviors and positive values to create a positive working environment.Be individually accountable for the consistent equipment performanceBe accountable for assigned deliverables on key capital projectsSuggest design modifications to address risks and design in quality and safety.Provide oversight for verification deliverables developed by outsourced/contract verification staff.Act as a liaison between Engineering and Quality Assurance 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 activitiesRelated Activities:Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.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 using risk-based approachesDefend the equipment-specific calibration, maintenance, & validation as required during regulatory inspectionsParticipate in internal audits and assess in conjunction with quality assuranceAssist in developing and maintaining business metric performanceTop Must Have Skill Sets:Fundamental client Leadership and Values - preferable to see former client workersGood Communication / Safety / Quality FocusedFundamental Technical KnowledgeDay to Day Responsibilities:Support Epogen Commercial manufacturing equipmentModel leadership behaviors and positive values to create a positive working environment.Be individually accountable for the consistent equipment performanceBe accountable for assigned deliverables on key capital projectsSuggest design modifications to address risks and design in quality and safety.Provide oversight for verification deliverables developed by outsourced/contract verification staff.Act as a liaison between Engineering and Quality Assurance 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 activitiesBasic Qualifications:Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experiencePreferred Qualifications:Bachelor's degree in engineering or another science-related field7+ years of relevant work experience with 5+ 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 GMP process equipment / automation projects, including validation protocol development and executionExperience with combination product / medical device quality systems verificationProcess equipment knowledge – basic principles of cell culture, fermentation, purification, fillingProcess automation knowledge – fundamental understanding of automation infrastructureKnowledge of Delta V, Rockwell, and Plant Information Systems is a plusRed Flags:Safety not recognized as top priorityPoor communicationHas issues under stressful situationsBlames other for negative situationsInterview Process:One phone screen/onsite interview.