Senior Engineer
Beacon Hill - thousand oaks, CA
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JOB DESCRIPTION: This engineering position supports manufacturing activities associated with cGMP equipment and facilities in Thousand Oaks. The senior 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 Senior Engineer role will provide direct engineering technical support as follows:Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverablesAssist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.Suggest design modifications to address risks and design in quality and safety.Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.Recommend, evaluate, and manage performance of contract resourcesProvide oversight for verification deliverables developed by outsourcedcontract verification staff.Act as a liaison between engineering and quality assurance during project planning, execution, and closeoutEnsure that work executed with safety compliant practices and documented in accordance with cGMP good documentationReview and approve the commissioning reports, maintenance practices and parts, and drive productivity improvementRelated 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 safetyquality, 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 performanceBasic QualificationsDoctorate degree OR Master's degree & 3 years of engineering andor manufacturing experience OR Bachelor's degree & 5 years of engineering andor manufacturing experience OR Associate's degree & 10 years of engineering andor manufacturing experience OR High school diploma GED & 12 years of engineering andor manufacturing experiencePreferred Qualifications Skills ExperienceBachelor's degree in engineering or another science-related field7+ years of relevant work experience with 5+ years' experience in operationsmanufacturing environmentDirect experience with regulated environments (FDA, OSHA, EPA, etc.)Working knowledge and experience with cGMP procedures and engineering practices on pharmaceuticalbiotech production processes, clean utilities, facilities, instruments, and equipmentExperience implementing risk-based verification on major GMP process equipment automation projects, including validation protocol development and executionUnderstanding and awareness of industryregulatory trends for verificationvalidationExperience with combination product medical device quality systems verificationStrong process equipment knowledge - cell culture, fermentation, purification, filling, and packagingStrong process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution verification.Knowledge 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.)
Created: 2024-09-30