Senior Process Engineer

Job Title: Senior Process Engineer Location: Spokane, WAIndustry: Pharmaceutical / BiotechPosition OverviewOur client is seeking a Senior Process Engineer / Lead Process Engineer with strong experience in the pharmaceutical and biotech industries to lead and execute a large-scale fill/finish technology transfer project.The ideal candidate will have hands-on experience supporting drug product manufacturing, fill/finish operations, technology transfer, process engineering, process validation, and GMP manufacturing environments. This individual should be able to quickly assess an existing manufacturing process, documentation, and technical package, identify gaps, and provide technical leadership through execution.The Senior Process Engineer will serve as the technical lead for the technology transfer, providing process engineering direction, validation strategy, process control guidance, and support for engineering, PPQ, and validation batches. Dedicated document-writing support will be available, so the primary focus will be on technical leadership, process knowledge, and execution.Key ResponsibilitiesLead large-scale fill/finish technology transfer activities from initial site intake through manufacturing execution and successful transfer.Review and assess existing process, batch, manufacturing, validation, and technology transfer documentation.Identify technical and documentation gaps and drive appropriate resolution with cross-functional teams.Develop and map the process control strategy to support technology transfer, process qualification, and validation.Provide hands-on technical support during engineering runs, process performance qualification (PPQ), validation batches, and manufacturing activities.Develop and own the overall process validation strategy, providing technical direction and content to supporting validation teams.Provide technical input and source content for protocols, reports, batch records, technology transfer documents, and other GMP documentation.Evaluate process risks, manufacturing constraints, equipment capabilities, and process parameters associated with the transferred process.Partner with Manufacturing, MSAT, Quality, Validation, Engineering, Regulatory, and external client teams to ensure successful technology transfer.Support troubleshooting and investigation of process deviations, manufacturing issues, and technical challenges during batch execution.Ensure technology transfer activities are executed in accordance with GMP, FDA, and applicable pharmaceutical/biotech quality requirements.Participate in process risk assessments, gap assessments, technical reviews, and readiness activities.Communicate project status, technical risks, issues, and execution priorities to internal stakeholders and external clients.Serve as the primary technical point of accountability for fill/finish technology transfer success.Required QualificationsBachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related engineering/scientific discipline.7+ years of process engineering experience within the pharmaceutical, biotech, or biopharmaceutical industry.Strong hands-on experience with drug product manufacturing and fill/finish operations.Proven experience leading or supporting technology transfer activities between manufacturing sites.Experience with process validation, PPQ, engineering batches, and validation batch execution.Strong understanding of GMP/cGMP manufacturing requirements and FDA-regulated environments.Experience reviewing manufacturing and technology transfer documentation and identifying process or documentation gaps.Strong knowledge of process control strategies, process parameters, critical process parameters (CPPs), and critical quality attributes (CQAs).Experience working cross-functionally with Manufacturing, Quality, MSAT, Validation, Engineering, and Regulatory teams.Ability to provide technical direction to document writers and validation teams.Strong technical writing, communication, problem-solving, and stakeholder-management skills.Preferred QualificationsDirect experience with aseptic processing and sterile fill/finish manufacturing.Experience with biologics, vaccines, injectables, or other sterile drug products.Experience supporting greenfield or large-scale manufacturing technology transfers.Experience with process characterization, continued process verification (CPV), and process lifecycle management.Experience with risk assessments, FMEA, deviation investigations, CAPA, and root cause analysis.Familiarity with ICH guidelines, FDA expectations, GAMP/GMP principles, and pharmaceutical validation practices.Experience working directly with external clients/CDMOs or contract manufacturing organizations.Strong ability to work independently and provide immediate technical leadership in a fast-paced manufacturing environment.Ideal CandidateThe ideal candidate is a senior-level pharmaceutical/biotech process engineer who can step into an existing fill/finish operation, quickly understand the process and technical package, identify gaps, and lead the site through technology transfer, engineering runs, PPQ, and validation execution.Drug product and sterile fill/finish experience is highly preferred.