Process Engineer II

Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support the execution of the Commissioning, Qualification, and Validation activities for our new Vial Filling system (e.g., washing/depyrogenation, aseptic filling, isolator/VPHP, glove integrity testers, environmental monitoring systems), including SAT, IQ/OQ, PQ, and Aseptic Process Simulation.
• Management of Equipment Vendors, including project execution, on‑site maintenance and calibration visits, vendor‑supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts criticality assessments.
• Responsible for delivering cycle development for the process including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation for filling process and recipes.
• Support the establishment of an electronic batch record system for filler and isolator setup, operation, and changeover.
• Support the transition from project to sustaining manufacturing and the ramp‑up of production volumes in the future by improving equipment reliability through Continuous Improvement and TPM processes.
• Coordinate technical deliverables within the Aseptic Operations team to support successful process and product launches.
• Lead and participate in cross‑functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimisation using tools such as DMAIC and FMEA.
• Manage change in the Vial Filling and/or Nest Filling areas as per site change control procedures.
• Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).
• Bachelor’s degree in engineering, Materials Science, Biology, or related discipline.
• Minimum 4+ years working in a cGMP environment, i.e. pharmaceutical, medical device.
• Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment.
• Front‑line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills across various levels of the organization.
• Strong Mechanical Aptitude.
• Interact with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects.
• Ability to execute on‑floor activities such as FAT, SAT, IQ/OQ, and Engineering batches.
• Willingness to adapt to changing priorities as project demands change.
• Ability to explain complex technical issues to external customers/agencies.

• SME‑level knowledge of high‑speed aseptic filling and barrier system technology (isolator, RABS).
• Expertise in single‑use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Demonstrated management and delivery of large capital projects ($1MM +).
• Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.

Not Applicable

Full‑time

• Manufacturing
• Pharmaceutical Manufacturing

• Medical insurance
• 401(k)