Job Description

Job Description

We are searching for a Process Engineer with experience 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 VA facility, which is nearing completion, will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines.

During the project phase, you will primarily manage OEMs and engineering services providers through commissioning, qualification, and validation and lead process development for two recently installed high-speed filling lines. During the operational phase, you will be the 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, fulfilling Client's mission to “Do what’s in the best interest of patients.”

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, 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-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.

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