Process Engineer IV

About the role

The Process Engineer IV plays a crucial role in advancing our customers' therapies from curiosity to cure. This position requires a deep understanding of cGMP and FDA regulations, and involves collaborating with cross-functional teams to drive process improvements and ensure compliance.

Responsibilities

• Develop batch records for client-specific formulation and filling operations.
• Oversee processing operations, including equipment preparation, bulk product formulation, sterile filtration, and filling support.
• Operate as an SME for GMP investigations (e.g., CAPA, departures, CCRs) and finalize closure reports for departures.
• Direct client interaction for routine discussions, summarizing engineering-related work completed verbally and in writing.
• Identify and specify process-specific equipment needed for clients' tech transfer, and develop techniques and process parameters specific to the client's product.
• Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
• Develop new manufacturing processes to meet client requirements.
• Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.

Requirements

This role requires a minimum of eight (8) years of experience in a cGMP/FDA, regulated environment. Experience with aseptic fill/finish is preferred, and there may be supervisory responsibilities involved.

Qualifications

• Bachelor’s degree in Biology, Chemical Engineering, or a related field.
• Strong communication and problem-solving skills.
• Proficiency in Microsoft Office tools.
• Ability to lift up to 25 pounds occasionally and up to 50 pounds infrequently.
• Pass a background check and drug screen.

Skills

• Technical proficiency in manufacturing and internet software.
• Strong mathematical skills, including algebra and geometry.
• Effective communication and presentation skills.
• Ability to interpret technical instructions and governmental regulations.

Benefits

Curia offers a comprehensive benefits package, including:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation, and holidays
• Career advancement opportunities
• Education reimbursement
• 401k program
• Learning platform
• And more!

Pay

Compensation details are confidential and will be shared during the interview process.

Schedule

The schedule for this role is flexible and can vary based on project needs and team dynamics.