Senior Process Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

· 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 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 4 years working in a cGMP environment, i.e. pharmaceutical.

· 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-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.

PREFERRED QUALIFICATIONS

· 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.