Process Engineer - Pharma (Buffalo)

Job Title: Process Engineer - PharmaLocation: Buffalo, NYDuration: 6- 12 MonthsSummary:We are looking for Process Engineers with strong pharmaceutical manufacturing and process validation experience to support process improvement, compliance, and validation activities within a GMP-regulated environment.Job Responsibilities:Support pharmaceutical manufacturing and process engineering activities in GMP-regulated environmentsReview and maintain Batch Manufacturing Records (BMRs) and related production documentationParticipate in GMP audits and ensure compliance with regulatory and quality standardsPerform Root Cause Analysis (RCA) for process deviations, nonconformances, and manufacturing issuesSupport Design Control and risk management activities including FMEA/PFMEAAnalyze process trends and perform statistical analysis to identify process improvementsExecute and support Process Validation activitiesPerform Gauge R&R studies and support process capability analysisCollaborate with Quality, Manufacturing, Validation, and Engineering teams to resolve production and compliance issuesAssist in continuous improvement initiatives related to manufacturing processes and operational efficiencyRequired Experience:1+ years of genuine hands-on Process Engineering experience within Pharmaceutical or GMP manufacturing environmentsExperience with GMP compliance and GMP audit supportKnowledge of Design Control processesExperience performing FMEA/PFMEA and Root Cause AnalysisHands-on experience with Batch Manufacturing Records (BMRs)Understanding of process trends, statistical analysis, and process capability studiesExperience supporting Process Validation activitiesFamiliarity with Gauge R&R methodologiesStrong documentation and cross-functional communication skillsPreferred Qualifications:Pharmaceutical manufacturing industry experienceExperience supporting validation or quality engineering teamsKnowledge of FDA and GMP regulatory requirements