Engineer - Process Engineering

About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally. Position Overview The Engineer is responsible for ensuring the reliability, performance, and compliance of assigned biotechnology process equipment. This role supports daily manufacturing operations by acting as the subject matter expert for equipment, leading troubleshooting and investigations, and driving continuous improvement initiatives. The engineer works closely with cross-functional teams to maintain equipment in a validated state, support new product introductions (NPI), and contribute to engineering projects, ensuring minimal disruption to operations and sustained production efficiency. Key Responsibilities Own and manage assigned process equipment to ensure safe, compliant, and reliable operations Act as subject matter expert for equipment performance, troubleshooting, and optimization Lead equipment breakdown investigations and perform root cause analysis Develop and implement corrective and preventive actions (CAPA) Manage deviations and change controls related to equipment performance Collaborate with cross-functional stakeholders to resolve operational issues Support equipment readiness for NPI and product changeovers Perform equipment assessments during qualifications and change activities Develop and optimize maintenance strategies (e.g., preventive maintenance, job plans in Maximo) Ensure completion of periodic reviews, data integrity, and security assessments Analyze and present data for operational issues and engineering projects Support site projects as SME or System Owner, including design reviews and technical transfers Participate in equipment installation, system walkdowns, and project handovers Drive continuous improvement initiatives using operational excellence and data analysis tools Benchmark equipment performance and implement reliability improvements Required Qualifications Degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field Experience in biopharmaceutical or biotechnology manufacturing environment Strong knowledge of process equipment, single-use systems, and GMP requirements Experience with deviation management, CAPA, and change control processes Hands-on troubleshooting and root cause analysis experience Familiarity with maintenance systems (e.g., Maximo) is an advantage Experience supporting NPI, CQV, or…