Director of Engineering

Director of EngineeringBe part of something bigger"”where every role contributes to creating hope for patients around the world. In this organization, breakthrough science is transformed into real-world therapies that change lives. Team members across global locations collaborate to bring innovative cell and gene therapies from concept to commercialization.You'll join a purpose-driven environment focused on innovation, collaboration, and patient impact. Whether working in the lab, cleanroom, or supporting operations, your contributions will directly enable life-saving treatments and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, this is an opportunity to help shape the future of medicine"”one patient at a time.Position SummaryResponsible for directing all facilities functions to ensure operational business units are supplied with the necessary physical infrastructure to meet organizational objectives, including facility maintenance, engineering, and metrology.Key responsibilities include preventative maintenance of facilities and systems, monitoring and calibration, managing engineering change control, troubleshooting equipment and processes, maintaining up-to-date as-built engineering drawings and Validation Master Plan, managing external contractors, and supervising a Facilities team operating within current Good Manufacturing Practices (cGMP) and cleanroom standards.This role also collaborates with internal departments, vendors, and commercial partners, assesses facility fit for incoming programs, and establishes operational structures to support multi-shift operations.Additionally, the position oversees metrology services during start-up, commissioning, validation, and capital improvements of multi-product manufacturing and testing facilities.Essential Functions and ResponsibilitiesDirect Facilities and Metrology servicesDevelop budget projections, material plans, and staffing forecastsDevelop SOPs, test reports, out-of-tolerance notifications, and validation protocolsEstablish calibration schedules aligned with business and customer goalsImplement preventative maintenance forecasting with continuous improvementMaintain personnel policies, procedures, and production control systemsEnsure all facility equipment is maintained, calibrated, qualified, and/or validatedEvaluate new production procedures and technologiesConduct failure analysis, root cause investigations, and corrective actionsUpdate as-built drawings as requiredOptimize use of equipment, facilities, and personnel for efficiencyRecommend process and operational improvementsLead capital improvement projectsPlan facility organizational structure to support growth and site master planningGenerate maintenance, engineering, and metrology performance summariesDevelop and implement effective staff training programsCommunicate routine and non-routine updates to leadership and stakeholdersLead investigations related to deviations and out-of-tolerance conditionsManage contractors for construction, renovation, and validation activitiesCoordinate with suppliers and vendorsContribute to strategic planning with senior leadershipManage team performance, coaching, and developmentSupport flexible operations, including off-hours support when requiredPerform additional duties as neededKnowledge, Skills & AbilitiesStrong leadership and team management capabilitiesDeep understanding of regulatory compliance for biologics manufacturingKnowledge of contract manufacturing operations and business needsHigh mechanical and technical aptitudeExcellent written and verbal communication skillsAbility to interpret and communicate complex technical informationStrong analytical and problem-solving abilitiesExperience evaluating technical data and producing documentationSound decision-making skills in complex environmentsAbility to work collaboratively and independentlyStrong attention to detail and data accuracyEducation & ExperienceBachelor's degree in a technical discipline (Mechanical, Electrical, Chemical Engineering, or related field)Minimum of 10 years of engineering experienceMinimum of 5 years of supervisory experience in a related technical fieldAt least 5 years of experience in a cGMP life sciences environmentLeadership ResponsibilitiesPromote a diverse and inclusive workplace cultureEnsure compliance with all applicable laws, regulations, and internal policiesRecruit, develop, and retain high-performing talentSet performance expectations and drive employee engagementSupport career development and organizational growthBuild strong customer relationships and deliver customer-focused solutionsMaintain transparent and effective communication across teamsAdapt to changing priorities and ambiguous environmentsUphold the highest ethical standards and confidentialityDemonstrate strong autonomy and decision-making capabilityQuality RequirementsEnsure compliance with FDA and global quality and regulatory standardsFollow established procedures and protocolsMaintain a strong focus on continuous training and developmentUphold data integrity and accuracy across all responsibilitiesSupport operational excellence through adherence to quality systems

Created: 2026-05-08