Senior EngineerThe Senior Engineer independently leads and directs process optimization, troubleshooting, system/facility modifications, and capital project activities within operations, manufacturing, pilot plant, and engineering environments. This role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.Key ResponsibilitiesExecute complex or novel engineering assignments requiring development of new or improved techniques and procedures.Develop engineering policies and procedures impacting multiple organizational units.Apply advanced engineering techniques and adapt specialized methods to diverse assignments.Utilize engineering knowledge beyond core discipline to support cross-functional initiatives.Serve as a peer-recognized SME responsible for determining methodologies in at least one engineering technology area.Apply mature engineering judgment in planning and conducting projects.Develop technical solutions to complex problems requiring creativity, innovation, and engineering expertise.Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for major system or facility modifications.Partner with Project Managers to deliver engineering projects within schedule, budget, and quality expectations.Coordinate external consultants, architects, and engineering firms in developing standard design documentation.Develop departmental or multi-disciplinary project budgets and manage cost controls for assigned areas.Own change controls for manufacturing process changes.Support major/trend deviation investigations, including root cause analysis, CAPA determination, authoring investigation reports, and presenting during regulatory inspections.Support risk assessments and microbial evaluation activities.Design, coordinate, and support execution of functional tests, water tests, and challenge runs for major changes or campaign readiness; generate technical protocols as needed.Provide guidance during MBR (Master Batch Record) creation and revisions.Perform assessments supporting process, automation, or equipment modifications and special projects.Complete assessments for new or modified BOMs (Bill of Materials).SkillsWorking knowledge of pharmaceutical/biotech processesFamiliarity with validation processes and protocol executionExperience with documentation in highly regulated environmentsAbility to operate specialized laboratory and engineering equipmentAbility to interpret and apply GLP, GMP, GDPAbility to apply engineering science to production systemsAbility to develop solutions to technical problems of limited to moderate scopeStrong problem-solving and applied engineering skillsTechnical report writing and verbal communication skillsUnderstanding of validation requirements for new equipment installationsAbility to manage multiple projects simultaneouslyAbility to determine when internal or external resources are requiredCollaboration, facilitation, schedule development, and project management skillsAbility to delegate and manage project work of othersWorking knowledge of financial analysis toolsLeadership, conflict resolution, negotiation, and vendor/contractor managementRequired EducationDoctorate in Engineering, ORMaster's degree + 2 years of engineering experience, ORBachelor's degree in Engineering + 4 years of engineering experiencePreferred QualificationsIn-depth experience with bio-processing unit operationsKnowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why's, Kepner-Tregoe)Familiarity with Lean Manufacturing practicesStrong communication and collaboration skills across manufacturing, process development, and qualityProficiency in GDP within regulated environmentsExperience with systems such as TrackWise, Spotfire, CDOCS, and process monitoring platformsStrong technical writing and presentation skillsExcellent written and verbal communication skills in English and Spanish6-month contract with possible extensionAdministrative shift