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Process Engineer
2 months ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.
Job DescriptionWe are seeking a Process Engineer with expertise in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system technology, and single-use fluid path components. The successful candidate will be responsible for managing OEMs and engineering services providers through commissioning, qualification, and validation, and leading process development for high-speed filling lines.
Key Responsibilities:- Support execution of Commissioning, Qualification, and Validation activities for new Vial Filling systems, including SAT, IQ/OQ, PQ, and Aseptic Process Simulation.
- Manage 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.
- Deliver 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 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).
- Bachelor's degree in engineering, Materials Science, Biology, or related discipline.
- 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, and fluency in English.
- Strong Mechanical Aptitude.
- 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.
- 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.
