Process Engineer III
Curia · Albuquerque
NPI Process Engineer III in Albuquerque, NM
Build your future at Curia, where our work has the power to save lives.
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 to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
We proudly offer
- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401K program with matching contributions
- Learning platform
- And more!
As a member of the NPI Tech Transfer Team, this position is responsible for supporting New Product Introduction (NPI) and technology transfer activities within their assigned functional area (e.g., Quality, Technical Operations, Validation, Microbiology, Analytical Sciences, Manufacturing, etc.). This role serves as the primary Subject Matter Expert (SME) for the functional area throughout the NPI lifecycle, providing technical leadership, risk assessment, planning, execution support, and operational readiness to ensure successful transfer and efficient commercialization of new products.
Working as a core member of the NPI Tech Transfer Team, the SME collaborates closely with Program Management, Operations, Quality, Regulatory, as a member of the customer-facing team, working to drive project execution through Tech Transfer stage gates, facilitate knowledge transfer, identify and mitigate risks, and ensure compliance with site procedures, regulatory requirements, and customer expectations. The position is dedicated to NPI activities and serves as the functional customer-facing point of contact for multiple concurrent tech transfer programs.
The Process Engineer III serves as a technical program lead responsible for driving technology transfer, process design, and scale-up execution for multiple client manufacturing programs. This role acts as a primary technical interface for client programs and provides technical guidance to supporting team members and instruction on site-driven projects.
Essential Duties and Responsibilities:
NPI Duties & Responsibilities:
- Act as the designated functional SME for all 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 required for Tech Transfer stage gates.
- Provide technical expertise during 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 in accordance with established procedures and project timelines.
- Drive operational readiness activities necessary to support development, validation, and commercial manufacturing.
- Support knowledge transfer activities between sending and receiving organizations, ensuring effective and efficient transfer of process, product, analytical, and operational knowledge.
- Participate in Technical Review Boards (TRBs), stage gate reviews, and leadership governance meetings.
- Collaborate with cross-functional departments to resolve technical challenges and remove execution barriers.
- Contribute to continuous improvement of NPI and Tech Transfer processes, tools, templates, and best practices.
Tech Transfer & Program Leadership:
- Lead technology transfer and scale-up activities 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, managing project timelines and presenting technical deliverables independently.
- Direct technical discussions and investigations, summarizing engineering-related work completed as written. Client communication will be supported by more senior-level engineers, as needed.
- Independently maintain project timelines and engineering deliverables, lead technical discussions, and present project status updates.
Process & Equipment Design:
- Develop new procedures to meet facility and client requirements. Adhere to safety requirements at all times.
- Specify and qualify process-specific equipment (e.g., single-use systems, mixing vessels, homogenizers and filtration setups) based on facility and program requirements.
- Author standard operating procedures, work instructions, and other applicable process documentation.
Quality & Compliance Ownership:
• Act as a Subject Matter Expert for cGMP quality events, leading deviations, root-cause investigations, CAPAs, and Change Control Requests from initiation through closure.
Floor Support & Training:
- Provide technical oversight during critical engineering and cGMP batch runs, providing guidance and task-level direction to supporting engineering staff.
- Design and deliver technical training on general and client specific manufacturing processes and facility workflows to cross-functional teams.
Technical Mentorship:
• Provide guidance, technical instruction, and project direction to junior engineers and supporting technical staff.
General Responsibilities:
- Read/interpret SOPs to ensure compliance
- Maintain up to date trainings
- Other duties as assigned
Education and Experience:
- Bachelor’s degree in chemical engineering, Bioengineering, or related scientific/engineering discipline.
- Minimum of five (5) years’ 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, Pre-Use Post-Sterilization Integrity Testing (PUPSIT), CIP/SIP, container closure systems, and lyophilization.
Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Other Skills and Abilities:
- Provides guidance and mentorship to team members
- Fosters a collaborative and positive work environment
- Champions change
- Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
- Demonstrates strong attention to detail and technical writing competency.
- Able to work independently to balance completing multiple tasks and drive projects to completion.
- Excellent communication skills. Meticulous and organized.
- Working knowledge of process engineering processing aids such as sanitary connections, valves, powder containment and pharmaceutical process design.
Other Qualifications:
Must pass a background check
Must pass a 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
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
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