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.