Manufacturing Process Engineer

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and

include the following but other duties may be assigned.

· Support technical activities related to new and existing products, process optimization, process & equipment troubleshooting, and process validation. The technical support includes Advanced Filling Isolator technology line(s) and appropriate equipment that helps function or is part of the overall Filling Isolator.

· 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

· Approves validation protocols or other relevant documents as needed

· 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

· Leads Manufacturing investigations and CAPA initiatives as needed.

· Writes and executes engineering protocols as needed.

· This position may require overtime and/or weekend work.

· Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and guidelines

· Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• ✓Stationary Position: 3/4 of the day and up.
• ✓Move, Traverse: From 1/4 to 1/2 of the day.
• ✓Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• ✓Install, place, adjust, apply, measure, use, or signal: None.
• ✓Ascend/Descend or Work Atop: Up to 1/4 of the day.
• ✓Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
• ✓Communicate or exchange information: 3/4 of the day and up.
• ✓Detect, distinguish, or determine: 3/4 of the day and up.
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Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Ø Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.

Ø The noise level in the work environment is typically, moderate.

The

listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable