Process Engineer

Key Responsibilities Provide process engineering support to pharmaceutical manufacturing operations to ensure safe, reliable, and efficient production. Monitor and optimize manufacturing processes to improve productivity, product quality, and operational efficiency. Support equipment troubleshooting, process investigations, and implementation of corrective and preventive actions (CAPA). Lead or support deviation investigations, root cause analysis, and change control activities in accordance with GMP requirements. Manage equipment, facility, and process changes through the site Change Management system. Support commissioning, qualification, and start-up of new manufacturing equipment and systems. Execute and coordinate small to medium-sized Capital (CapEx) projects, including design review, procurement, installation, commissioning, and qualification. Collaborate with Production, Maintenance, Quality, Validation, Engineering, EHS, and external vendors to deliver engineering solutions. Develop and update SOPs, engineering documents, risk assessments, and technical reports. Perform process optimization initiatives to improve yield, throughput, equipment reliability, and cost efficiency. Participate in Process Hazard Analysis (PHA), HAZOP, FMEA, and other Process Safety Management (PSM) activities. Support internal and external regulatory inspections by providing engineering and technical expertise. Ensure all engineering activities comply with cGMP, safety regulations, engineering standards, and company procedures. Drive continuous improvement projects using Lean Manufacturing and Six Sigma methodologies where applicable. Support energy-saving, sustainability, and cost-reduction initiatives across manufacturing operations. Requirements Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or a related Engineering discipline. Minimum 3–8 years of Process Engineering experience within the pharmaceutical, biotechnology, API, chemical, or life sciences industry. Experience supporting GMP/cGMP manufacturing operations. Knowledge of pharmaceutical manufacturing equipment and unit operations. Experience with commissioning, qualification (CQV), equipment start-up, and validation activities. Familiarity with deviation investigations, CAPA, Change Control, and Root Cause Analysis. Experience participating in Process Safety Management (PSM), HAZOP, PHA, FMEA, or Risk Assessments is advantageous. Exposure to Capital Projects (CapEx), equipment procurement, FAT/SAT, and project execution. Strong project management and stakeholder management skills. Excellent troubleshooting, analytical, and problem-solving abilities. Strong communication skills with the ability to work effectively across cross-functional teams. Preferred Skills Knowledge of GMP, FDA, EMA, PIC/S, and ICH guidelines. Experience with API, biologics, or sterile manufacturing processes. Lean Manufacturing, Six Sigma, or Continuous Improvement experience. Familiarity with SAP, Maximo, DeltaV, MES, or other manufacturing systems is an advantage. Understanding of engineering documentation, SOP development, and technical writing.