Our client is hiring a Process Engineer to join the Process Development Commercial Support team.Key Responsibilities:Provide day-to-day operational support as a subject matter expert in drug product formulation, aseptic filling (vials and pre-filled syringes), lyophilization, and capping.Lead and contribute to product and process investigations, including assessment of product impact related to deviations, excursions, and change controls.Support new product introductions as a process SME, including recipe development, protocol execution, troubleshooting, and investigation support.Drive continuous improvement initiatives to enhance process performance, productivity, and line reliability through risk assessments, gap analysis, and mitigation strategies.Review and approve changes to operating procedures, electronic batch records, and product technical documentation to ensure compliance and process robustness.Perform data trending and performance analysis to identify, troubleshoot, and resolve adverse process and operational trends.Key Requirements:Bachelor's or Master's degree in Engineering, Science, or a related discipline with ~6 years of relevant industry experience, or a PhD with ~3 years of directly related experience.Proven experience in drug product manufacturing, including formulation, vial or pre-filled syringe filling, and/or lyophilization.Demonstrated leadership capability with the ability to influence, build effective teams, and work across cross-functional and external stakeholders.Experience supporting new product introduction (NPI), process development, or MSAT activities within a GMP-regulated environment.Strong understanding of pharmaceutical manufacturing processes, investigations, and technical problem-solving in commercial operations.Lean, Six Sigma, or other continuous improvement qualifications or experience are considered an advantage.