Aseptic Manufacturing Technician

About the role

The Process Engineer is responsible for identifying and mitigating manufacturing issues (i.e., Aseptic Filling, Capping/Lyo operations, etc.) for existing business, through strong engineering and process improvement methods. The Manufacturing Process Engineer will play a critical role in creating/maintaining/improving manufacturing processes and procedures. They will also lead/assist in the commissioning, qualification, and validation of process equipment.

Responsibilities

• Support technical activities related to new and existing products, process optimization, process & equipment troubleshooting, and process validation.
• Provide data gathering and analysis as needed to support technical projects and minimize waste and variability in the manufacturing process.
• Maximize the success rate for manufacturing operations by instituting programs to minimize human error, mechanical failure, filling isolator contaminations, procedural error(s) and improve yield/efficiency.
• Write standard operational procedures (SOPs), standard test procedures, Engineering batch records, and other related GMP documents. Assist in the training of appropriate personnel.
• Responsible for troubleshooting process manufacturing equipment, supporting corrective action initiatives, and collaborating in ensuring utilities and manufacturing equipment meet operating specifications and remain compliant as required per SOPs and regulatory regulations.
• Maintain a safety-first approach to manufacturing process development and manufacturing.
• Commissioning of equipment, including all necessary change controls and training, including leading FAT & SAT activities. Evaluate and test new equipment and processes. This may include coordination of outside design, integration, and equipment manufacturing services.
• Research new trends and technologies in advanced aseptic filling/manufacturing. Evaluate and test new equipment and processes. This may include coordination of outside design, integration, and equipment manufacturing services.
• Collaborates with appropriate personnel on the development of new manufacturing equipment performance requirements.
• Leads Manufacturing investigations and CAPA initiatives as needed.
• Writes and executes engineering protocols as needed.

Qualifications

• Minimum of 3-6 years working in a Pharma cGMP environment; equivalent combination of education and experience will be considered.
• Must have experience with one of the following : Autoclave & depyrogenation oven, Vial fillers/cappers, ISO 5 experience.
• Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment preferred.
• Ability to manage teams to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches. Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement.
• Intermediate/Strong Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs to support the operation of the Aseptic Filling Isolator and its relevant equipment/parts.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.