Process Engineer IV

Curia • Albuquerque, NM

1d • Onsite

About The Position

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments. The Process Engineer IV executes and oversees advanced engineering functions, including process design, scale-up, and documentation control. The role collaborates with R&D, Quality Assurance, and Production to provide technical leadership, improve processes and operational efficiency, and ensure compliance with cGMP and FDA regulations.

The position develops batch records for client-specific formulation and filling operations; oversees engineering and GMP processing, including equipment preparation, bulk product formulation, sterile filtration, and filling support; and supports process design and internal technology transfer. With senior or managerial engineering support, the Process Engineer IV serves as a subject matter expert for GMP investigations and prepares closure reports for assigned departures. The role also communicates directly with clients about routine engineering work, identifies equipment and process parameters for client technology transfers, authors equipment and cleanroom process instructions, and develops manufacturing processes to meet client requirements.

The position is based in Albuquerque, New Mexico. Work may take place in an office, manufacturing, or warehouse environment. In sterile manufacturing areas, aseptic gowning and task-dependent personal protective equipment are required. The role may involve exposure to wet or humid conditions, confined spaces, cold storage temperatures, cleaning agents, and other manufacturing or warehouse conditions.

Requirements

• Bachelor’s degree in Biology, Chemical Engineering, or a related field and at least 8 years of experience in a cGMP/FDA-regulated environment; alternatively, a master’s degree in one of these fields and at least 6 years of such experience.
• Ability to read and interpret safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, including presentation skills and the ability to respond to questions from groups of managers, clients, customers, and the public.
• Ability to perform arithmetic operations across units of measurement and a strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, draw valid conclusions, interpret technical instructions in mathematical or diagram form, and handle abstract and concrete variables.
• Strong technical foundation and ability to use manufacturing and internet software and Microsoft Office applications, including PowerPoint, Excel, Word, and Outlook.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening and obtain and maintain gowning certification.

Nice To Haves

• Experience with aseptic fill/finish is preferred.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.

Responsibilities

• Develop batch records for client-specific formulation and filling operations.
• Oversee engineering and GMP processing operations, including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer.
• Serve as a subject matter expert for GMP investigations, including CAPA, departures, and CCRs, with senior or managerial engineering support.
• Finalize closure reports for departures assigned to process engineering.
• Discuss routine matters directly with clients and summarize completed engineering work verbally and in writing, with support from more senior engineers as needed.
• Identify and specify process-specific equipment needed for client technology transfers.
• Develop techniques and process parameters specific to client products while maintaining critical product attributes.
• Author instructions for equipment operation and process flows in the cleanroom facility.
• Develop new manufacturing processes to meet client requirements.
• Follow safety requirements and raise process deviations to the shift supervisor, engineering manager, and/or Quality Assurance.
• Provide mentoring, guidance, and advice as needed; the role has no supervisory responsibilities.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior