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Process Engineer V

1 month ago

Albuquerque, New Mexico, United States curiate Full time
Job Title: Process Engineer V

Job Summary:

The Process Engineer V will lead the facilitation of technology transfer for client processes, ensuring seamless integration into manufacturing operations.

Key Responsibilities:

  • Develop batch records for client-specific formulation and filling operations.
  • Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer.
  • Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as written.
  • Identify and specify process-specific equipment needed for clients' tech transfer, and develop techniques and process parameters specific to the client's product while maintaining critical product attributes.
  • Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
  • Develop new manufacturing processes to meet client requirements.
  • Adhere to safety requirements at all times.
  • Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.

Requirements:

  • Bachelor's degree in Biology, Chemical Engineering, or a related field.
  • Minimum 12 years relevant experience in a cGMP/FDA-regulated environment with experience with aseptic fill/finish.
  • Experience with SIP is preferred.

Working Environment:

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required.

Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand.

The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration.

In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.