Process Engineer IV

Curia•Albuquerque, NM

1d•Onsite

About The Position

Curia is a global contract development and manufacturing organization (CDMO) with more than 30 years of experience partnering with pharmaceutical and biotech companies. The Process Engineer IV will execute and oversee advanced engineering functions, including process design, scale-up, and documentation control. The role provides technical leadership and expertise while working closely with R&D, Quality Assurance, and Production to improve processes, enhance operational efficiency, and support compliance with cGMP and FDA regulations. The position supports client-specific formulation and filling operations, engineering and GMP processing, internal technology transfers, process development, and equipment selection. It also includes routine client communication and work on GMP investigations and process documentation. The role has no supervisory responsibilities, though it may involve mentoring, guiding, and advising others. The position is based in Albuquerque, New Mexico. Work may take place in an office, pharmaceutical manufacturing, or warehouse environment. Sterile manufacturing work requires aseptic gowning and task-dependent personal protective equipment. Employees may encounter wet or humid conditions, confined areas, refrigerator or freezer temperatures, cleaning agents, and other manufacturing or warehouse hazards.

Requirements

Bachelor’s degree in Biology, Chemical Engineering, or a related field and at least eight years of experience in a cGMP/FDA-regulated environment, or a master’s degree in one of these fields and at least six years of experience in a cGMP/FDA-regulated environment.
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.
Proficiency in arithmetic 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 work with abstract and concrete variables.
Ability to use manufacturing and internet software and Microsoft Office tools, including PowerPoint, Excel, Word, and Outlook.
Must pass a background check and drug screen.
May be required to pass Occupational Health Screening.
May be required to obtain and maintain gowning certification.
May be required to obtain and maintain media qualification.
May be required to wear a respirator.

Nice To Haves

Experience with aseptic fill/finish.

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.
With senior or managerial engineering support, serve as a subject-matter expert for GMP investigations, including CAPAs, departures, and CCRs, and finalize closure reports for departures assigned to process engineering.
Communicate directly with clients about routine matters and summarize engineering work verbally and in writing, with support from more senior engineers as needed.
Identify and specify process-specific equipment for client technology transfers.
Develop techniques and process parameters specific to client products while maintaining critical product attributes.
Author equipment operating instructions and document process flows in the cleanroom facility.
Develop new manufacturing processes to meet client requirements.
Follow safety requirements at all times.
Bring process deviations to the attention of the shift supervisor, engineering manager, and/or Quality Assurance.