Process Engineer

Process Engineer

This is an exciting opportunity as a Process Engineer that will serve as a technical leader and subject matter expert (SME) that is responsible for the design, implementation, optimization, troubleshooting, and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical products. This role provides strategic engineering support to ensure reliable, compliant, and high-performance aseptic manufacturing processes for injectable drug products (vials, syringes, cartridges, etc.). The engineer drives process optimization, contamination control, equipment lifecycle management, and continuous improvement while maintaining full compliance with cGMP, FDA, EMA, ISO, and other regulatory requirements.

Key Responsibilities

• Act as the primary SME for aseptic manufacturing equipment, utilities (WFI, clean steam, compressed gases), and fill-finish systems (vial washers, depyrogenation tunnels, isolators/RABS, filling lines, cappers, lyophilizers, robotic systems, etc.).
• Provide technical leadership for aseptic fill/finish operations, including process design, scale-up, process validation, troubleshooting, and ongoing performance monitoring.
• Ensure robust aseptic practices and contamination control strategies (CCS) are implemented and sustained across all sterile operations.
• Lead or support equipment and process lifecycle activities, including design reviews, FAT/SAT, IQ/OQ, requalification, and decommissioning.
• Author, review, and approve technical documents such as SOPs, batch records, change controls, deviations, CAPAs, risk assessments, validation protocols/reports, and investigation reports.
• Perform in-depth root cause analysis (using tools such as Fishbone, 5-Why, FMEA) on mechanical, automation, environmental and process deviations; author and implement CAPAs to drive permanent corrective solutions to improve yield, reduce downtime, and strengthen contamination control.
• Drive process optimization and continuous improvement initiatives using Lean, Six Sigma, and data-driven approaches to increase yield, reduce cycle time, minimize interventions, and enhance sterility assurance.
• Provide engineering oversight and troubleshooting support during manufacturing campaigns, including real-time shop-floor support for complex technical issues.
• Collaborate with Quality Assurance, Validation, Microbiology, Regulatory, Supply Chain, Operations and MSAT teams to ensure successful tech transfers, new product introductions (NPI), and regulatory inspections.
• Support regulatory submissions and inspections by preparing technical packages and defending aseptic processes.
• Lead or significantly contribute to change controls, process improvement projects, and capital projects aimed at enhancing sterility assurance, throughput, and operational efficiency.
• Author, review, and approve SOPs, batch records, preventive maintenance plans, calibration procedures, and engineering protocols/reports.
• Support cleanroom performance qualification activities including airflow visualization (smoke studies), particle monitoring, pressure cascade management, and personnel/material flow optimization.
• Mentor and provide technical guidance to junior engineers, manufacturing technicians, and cross-functional team members.
• Monitor and analyze process performance metrics (e.g., yield, intervention rate, environmental monitoring trends, downtime) and implement improvements.

Qualifications & Requirements:

Education

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.

Experience

• 1+ years of hands-on engineering experience in a cGMP regulated pharmaceutical, biopharmaceutical, or sterile medical device manufacturing environment.
• Experience with isolator technology, RABS, vial/syringe/cartridge filling lines, lyophilization, aseptic connections, and closed-system processing.
• Proven track record supporting sterile product manufacturing.

Preferred Technical Skills & Qualifications

• Proficiency in mechanical design software: SolidWorks, AutoCAD Inventor, or equivalent (required: creation of complex 3D models, assemblies, detailed drawings, and tolerance analysis).
• Automation knowledge: PLC programming (ladder logic, structured text), HMI/SCADA development, troubleshooting industrial control systems, and integration of robotic arms, servo systems, and vision technologies.
• In-depth knowledge of aseptic fill-finish equipment: peristaltic/rotary piston pumps, vial/syringe/cartridge fillers, stoppering/capping systems, isolators/RABS, VHP decontamination, and barrier technologies.
• Solid understanding of process control, instrumentation, sensors, actuators, and data acquisition systems.
• Familiarity with data analytics tools (Excel, Minitab, JMP, OSIsoft PI) for process monitoring, capability analysis, and statistical evaluation.
• Knowledge of cGMP requirements, EU Annex 1 contamination control strategy, sterility assurance, and cleanroom classification.
• Experience executing or leading process/equipment validation, media fills, and cleaning validation in aseptic environments.
• Exposure to lean manufacturing, Six Sigma, or reliability-centered maintenance methodologies.
• Previous involvement in capital project execution or technology transfer projects.

What We Offer

• Opportunity to take ownership of high-impact aseptic systems and automation projects.
• Exposure to state-of-the-art fill-finish and barrier technologies.
• Career development path toward Principal Engineer or technical leadership roles.
• Competitive salary, bonus eligibility, and comprehensive benefits package.
• Structured technical training and mentorship opportunities