Process Engineer, Aseptic Operations
Our client, a distinctive and rapidly growing pharmaceutical company, is looking to add a Process Engineer, Aseptic Operations to their team. During the project phase, you will primarily manage OEMs and engineering services providers through commissioning, qualification, and validation, and lead process development. During the operational phase, you will be System Owner/SME of a high-speed filling line, optimizing equipment uptime and process robustness as we continue to transfer products currently produced by contract manufacturing sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Support execution of the commissioning, qualification, and validation activities for new vial filling and nested presentation filling systems (e.g. washing/depyrogenation, aseptic filling, isolator/VPHP, glove integrity testers, environmental monitoring systems) including SAT, IQ/OQ, PQ, and Aseptic Process Simulation.
- Lead implementation of single-use technology. Together with materials suppliers, design sterile filtration and filling assemblies suitable for product- and process-specific requirements.
- 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 establishment of electronic batch record system for filler and isolator setup, operation, and changeover.
- Support transition from project to sustaining manufacturing and ramp-up of production volumes in 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 optimization 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).
BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor’s Degree in Engineering, Materials Science, Biology, or related discipline.
- Minimum 3-5 years working in a cGMP environment, i.e. pharmaceutical, medical device, or food and beverage manufacturing.
- Ability to manage teams of varying education levels and cultural backgrounds to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
- Ability to explain complex technical issues to external customers / agencies.
- 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.
- 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.