The posting
Job Description
Validation Engineer IV (NPI) 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 Validation Engineer IV is a senior-level professional responsible for leading the development, review, and execution of complex validation protocols supporting manufacturing, quality, and regulatory compliance. This role provides advanced technical expertise and strategic guidance on equipment, process, system, and computer system validations in accordance with cGMP, FDA regulations, and industry standards such as GAMP. The Validation Engineer IV leads cross-functional validation projects, coordinates validation activities across multiple departments, and ensures seamless integration with production and quality timelines. This role authors and approves comprehensive validation master plans, protocols, and technical reports while driving continuous improvement initiatives to optimize validation processes. Additionally, the Validation Engineer IV mentor’s junior validation staff, supports regulatory inspections and audits, manages validation-related investigations and deviations, and collaborates with external vendors and regulatory bodies. This position plays a key role in shaping validation strategies and ensuring organizational readiness for new product introductions and regulatory submissions. The role also includes providing technical support for new product introductions, equipment, re-qualification schedules, and ensuring plant readiness post-shutdowns.
Essential Duties and 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. • Lead the development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification. • Provide technical leadership for qualification and validation activities such as new product introductions, sterilization systems, computerized systems, cleaning validation, manufacturing / packaging equipment, cleanrooms, aseptic processing operations and critical utilities (water for injection / clean steam). • Provide technical leadership for qualification and validation activities such as new product introductions, sterilization systems, computerized systems, cleaning validation, manufacturing / packaging equipment, cleanrooms, aseptic processing operations and critical utilities (water for injection / clean steam). • Author, maintain, and approve comprehensive validation master plans ensuring full compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11. • Oversee and conduct validation testing activities, analyze data for accuracy, reliability, and compliance, and prepare detailed final reports with recommendations for adjustments or corrective actions. • Lead cross-functional collaboration to coordinate and integrate validation activities with production and quality teams, ensuring projects meet timelines with minimal disruption. • Provide expert technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid-level validation staff. • Manage relationships with external vendors and consultants to support validation projects and ensure adherence to quality and compliance standards. • Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations. • Develop and deliver technical training and support to personnel on validation methodologies, regulatory expectations, and quality standards. • Participate in special projects and perform additional duties as assigned by management to support departmental goals and organizational objectives. • Read/interpret SOPs to ensure compliance • Maintain up to date trainings • Other duties as assigned
Education and Experience: • Bachelor’s degree in science, Engineering, or relevant field with a minimum of eight (8) years relevant experience of pharmaceutical validation in an aseptic/sterile product environment OR • Master’s degree in science, Engineering, or relevant field with six (6) years relevant experience of pharmaceutical validation in an aseptic/sterile product environment • Experience with validation tools and processes, including temperature mapping and use of Kaye Validator / Ellab Loggers etc. • Experience with FDA and EU regulations for pharmaceuticals and validation requirements, preferred • Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance
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 • Proficiency in advanced mathematics (e.g., calculus) and technical writing
Other Qualifications: Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening Must 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.
