Process Engineer III

Curia • Albuquerque, NM

13h

About The Position

The Process Engineer III serves as a technical program lead for New Product Introduction (NPI) and technology transfer activities, driving process design, technology transfer, and scale-up for multiple client manufacturing programs. As a functional subject matter expert and customer-facing technical contact, the role supports programs from initiation through commercial launch, collaborating with Program Management, Operations, Quality, Regulatory, and other cross-functional teams to facilitate knowledge transfer, assess and mitigate risks, achieve operational readiness, and meet site procedures, regulatory requirements, customer expectations, and project timelines.

The position leads transfer and scale-up activities for formulation, sterile filtration, aseptic filling, and inspection and packaging operations. It develops and reviews batch records, engineering protocols, process flow maps, procedures, SOPs, work instructions, and other process documentation; specifies and qualifies process-specific equipment; and provides technical oversight during engineering and cGMP batch runs. The role also leads quality investigations and change controls, delivers technical training, and provides guidance and mentorship to junior engineers and technical staff. The position does not have supervisory responsibilities.

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 personnel and material flows, process design, and aseptic processing technologies is required. Candidates must pass a background check and drug screen, and may need to pass occupational health screening, obtain and maintain gowning certification or media qualification, and wear a respirator.

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; meticulous and organized.
• 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

• Act 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.
• Work 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, covering process, product, analytical, and operational knowledge.
• 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 continuous improvement of NPI and Tech Transfer processes, tools, templates, and practices.
• Lead technology transfer and scale-up for client formulation, sterile filtration, aseptic filling, and inspection and 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 present technical deliverables and project status updates.
• Direct technical discussions and investigations and document engineering work completed.
• Develop procedures to meet facility and client requirements while following safety requirements.
• Specify and qualify process-specific equipment based on facility and program requirements.
• Author SOPs, work instructions, and other process documentation.
• Lead cGMP quality events, including deviations, root-cause investigations, CAPAs, and Change Control Requests, from initiation through closure.
• Provide technical oversight during critical engineering and cGMP batch runs and task-level direction to supporting engineering staff.
• Design and deliver technical training on general and client-specific manufacturing processes and facility workflows.
• Provide guidance, technical instruction, and project direction to junior engineers and supporting technical staff.
• Read and interpret SOPs to ensure compliance and maintain up-to-date training.
• 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: Mid Level