Process Engineer III

Curia • Albuquerque, NM

22h • Onsite

About The Position

The Process Engineer III is a technical program lead supporting New Product Introduction (NPI) and technology transfer at Curia’s Albuquerque, New Mexico site. As a member of the NPI Tech Transfer Team, the role serves as the functional subject matter expert through the NPI lifecycle and leads technology transfer, process design, and scale-up for multiple client manufacturing programs. The position provides technical leadership, risk assessment, planning, execution support, and operational readiness to enable successful transfer and commercialization of new products.

The role collaborates with Program Management, Operations, Quality, Regulatory, and other cross-functional groups, and acts as a customer-facing technical contact for concurrent technology transfer programs. Responsibilities include supporting transfer and scale-up for formulation, sterile filtration, aseptic filling, and inspection and packaging; preparing and reviewing batch records, protocols, process maps, procedures, and other documentation; specifying and qualifying process equipment; and supporting compliant development, validation, and commercial manufacturing. The position also leads quality investigations and provides floor support, training, and technical guidance to junior engineers and supporting staff.

The role requires a bachelor’s degree in chemical engineering, bioengineering, or a related scientific or engineering discipline, and at least five years of engineering experience in a cGMP/FDA-regulated environment. Hands-on experience with aseptic fill/finish operations, cleanroom flows, and process design is required, along with working knowledge of aseptic processing technologies. The role has no supervisory responsibilities, though it includes mentoring and advising others.

Requirements

• Bachelor’s degree in chemical engineering, bioengineering, or a related scientific or engineering discipline.
• At least five years of experience as an engineer in a cGMP/FDA-regulated environment.
• Hands-on experience with aseptic fill/finish operations, cleanroom personnel and material flows, and process design.
• Strong working knowledge of aseptic processing technologies, including single-use strategies, sterile filtration, PUPSIT, CIP/SIP, container closure systems, and lyophilization.
• Working knowledge of process engineering aids such as sanitary connections, valves, powder containment, and pharmaceutical process design.
• Strong attention to detail and technical writing competency.
• Ability to work independently, balance multiple tasks, and drive projects to completion.
• Excellent communication skills and meticulous, organized work habits.
• Ability to foster collaboration, champion change, and promote a safe and healthy work environment.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.
• 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.

Responsibilities

• Serve as the designated functional subject matter expert for assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews.
• Support development and execution of project plans, timelines, and deliverables for Tech Transfer stage gates.
• Provide technical expertise in customer meetings, technical discussions, audits, and governance reviews.
• Partner with Program Managers to identify project risks, mitigation plans, and escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed according to procedures and project timelines.
• Drive operational readiness for development, validation, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations.
• Participate in Technical Review Boards, stage gate reviews, and leadership governance meetings.
• Collaborate across departments to resolve technical challenges and remove execution barriers.
• Contribute to improvement of NPI and Tech Transfer processes, tools, templates, and best practices.
• Lead technology transfer and scale-up for client formulation, sterile filtration, aseptic filling, and inspection/packaging operations.
• Generate and review batch records, engineering protocols, and process flow maps.
• Serve as the primary technical contact for routine client interactions; manage timelines and independently present technical deliverables and project updates.
• Direct technical discussions and investigations and summarize engineering work in writing.
• Develop procedures to meet facility and client requirements while adhering to safety requirements.
• Specify and qualify process-specific equipment, including single-use systems, mixing vessels, homogenizers, and filtration setups.
• Author SOPs, work instructions, and other process documentation.
• Lead cGMP quality events, deviations, root-cause investigations, CAPAs, and Change Control Requests from initiation through closure.
• Provide technical oversight and task-level direction during critical engineering and cGMP batch runs.
• Design and deliver technical training on manufacturing processes and facility workflows.
• Provide guidance, technical instruction, and project direction to junior engineers and supporting technical staff.
• Read and interpret SOPs, maintain current training, and perform other duties as assigned.

Benefits

• Generous benefit options, eligible from the first day of employment
• Paid training
• Vacation, with accrual beginning on the first day of employment
• Paid holidays
• Career advancement opportunities
• Education reimbursement
• 401(k) program with matching contributions
• Learning platform

What This Job Offers

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