Process Engineer I

Curia • Albuquerque, NM

6d

About The Position

The Process Engineer I facilitates technology transfer of client processes and performs engineering functions such as design, scale-up, and documentation. The position functions as a program lead under the direction of functional group leadership and guides supporting team members on project-related tasks.

The engineer leads batch record and process activities for client-specific formulation and filling operations, overseeing critical engineering and GMP operations such as equipment preparation, bulk product formulation, sterile filtration, and filling support. The role serves as a subject matter expert for GMP investigations from initiation through closure and communicates with clients about routine engineering work, with support from more senior engineers as needed.

The position identifies and specifies process equipment, authors equipment operating instructions and cleanroom process-flow details, develops procedures, and designs and provides training on operating tasks and client programs. The engineer is expected to follow safety requirements, read and interpret SOPs, maintain current training, and perform other assigned duties. The role has no supervisory responsibilities but may include mentoring, guiding, and advising team members.

Requirements

• Bachelor’s degree in Biology, Chemical Engineering, or a related field of study.
• Must pass a background check.
• Must pass a drug screen.
• Must be able to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.
• Strong attention to detail, communication, organization, and ability to work with a moderate amount of supervision.
• Ability to interact effectively with clients and internal departments.
• Must follow established safety protocols and actively identify and address potential hazards.

Nice To Haves

• Process engineering experience is preferred.
• At least two years of experience in the pharmaceutical or biotech industry is preferred.
• Experience with aseptic fill/finish is preferred.
• Familiarity with aseptic technique and cleanroom personnel flows is desirable.
• Knowledge of process flows, including disposables strategies, filtration, mixing strategies, and fluid transfer between vessels, is a plus.
• Working knowledge of process engineering aids such as sanitary connections, valves, and pharmaceutical process design.

Responsibilities

• Lead batch record and process activities for client-specific formulation and filling operations for at least one client.
• Oversee critical engineering and GMP operations, including equipment preparation, bulk product formulation, sterile filtration, and filling support.
• Serve as a subject matter expert for GMP investigations, such as CAPA, departures, and CCRs, from initiation to closure.
• Communicate directly with clients during routine discussions and summarize engineering work verbally and in writing, with support from senior engineers as needed.
• Identify and specify process-specific equipment based on facility, client, and program needs.
• Write equipment operating instructions and document process flows in the cleanroom facility.
• Develop procedures to meet facility and client requirements.
• Follow safety requirements.
• Design and provide training on operating tasks described in SOPs or work instructions.
• Provide training on client programs and processes.
• Read and interpret SOPs to ensure compliance and maintain up-to-date training.
• Guide and mentor team members and contribute to a collaborative, positive, and safe work environment.
• Perform other duties as assigned.

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 with matching contributions.
• Learning platform.

What This Job Offers

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