Manufacturing Specialist

Curia • Albuquerque, NM

5d • Onsite

About The Position

The Manufacturing Specialist supports New Product Introduction (NPI) and technology transfer activities as the Manufacturing subject matter expert (SME) on the NPI Tech Transfer Team. The role provides technical leadership, risk assessment, planning, execution support, and operational readiness throughout the NPI lifecycle to help transfer and commercialize new products successfully. It serves as a customer-facing functional contact for multiple concurrent technology transfer programs and works with Program Management, Operations, Quality, Regulatory, and other teams to facilitate knowledge transfer, manage risks, and meet site procedures, regulatory requirements, and customer expectations.

The position also supports daily manufacturing operations by aligning production processes, materials, documentation, and personnel. It provides manufacturing guidance for deviations, investigations, CAPAs, and documentation reviews; supports compliance with GMP and procedural requirements; and collaborates across functions to resolve production issues, improve safety, and drive continuous improvement. The role contributes to material procurement, SOP development and revision, training compliance, manufacturing readiness, and the removal of operational bottlenecks.

This position has no supervisory responsibilities, though it may involve mentoring, guiding, and advising others. The role is based in Albuquerque, New Mexico. Candidates must pass a background check and drug screen; an occupational health screening may also be required. The employee must be able to obtain and maintain gowning certification and media qualification, and be able to wear a respirator.

Requirements

• High school diploma or equivalent (GED).
• At least nine years of experience in a pharmaceutical manufacturing environment, including experience with Aseptic Processing, Formulation, and/or Fill-Finish Operations.
• Working knowledge of GMP-regulated manufacturing environments.
• Ability to cultivate a culture of continuous improvement and right-first-time quality.
• Ability to foster a collaborative and positive work environment and champion change.
• Ability to promote a safe and healthy work environment by identifying and addressing hazards, following safety protocols, participating in safety training, and encouraging awareness and responsibility.
• Strong attention to detail.
• Strong problem-solving, communication, and cross-functional collaboration skills.
• Ability to work effectively in a fast-paced manufacturing environment while maintaining quality and safety compliance.
• Must pass a background check and drug screen; may be required to pass an occupational health screening.
• Must be able to obtain and maintain gowning certification and media qualification, and be able to wear a respirator.

Nice To Haves

• Bachelor’s degree in Engineering, Business, Science, or a related field, with at least five years of pharmaceutical manufacturing experience, including Aseptic Processing, Formulation, and/or Fill-Finish Operations.
• Demonstrated leadership experience, such as Team Lead, Senior Technician, Path Guide, or another informal leadership role.
• Experience supporting deviation investigations, CAPAs, and process improvement initiatives.

Responsibilities

• Act as the designated Manufacturing functional SME for assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch, supporting implementation of new products and processes.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews, including identifying and resolving operational bottlenecks, process gaps, and execution barriers.
• Support development and execution of project plans, timelines, and deliverables for Tech Transfer stage gates, including activities supporting development, validation, and commercial manufacturing.
• Provide technical expertise in customer meetings, technical discussions, audits, governance reviews, and leadership meetings, and represent Manufacturing in relevant cross-functional forums.
• Work with Program Managers and cross-functional teams to identify project and operational risks, develop mitigation plans, and establish escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed according to procedures, project timelines, GMP requirements, and regulatory standards.
• Drive operational readiness for development, validation, and commercial manufacturing, maintaining working knowledge of manufacturing processes, production lines, equipment, and operational areas.
• Support knowledge transfer between sending and receiving organizations for process, product, analytical, and operational knowledge.
• Participate in Technical Review Boards, stage gate reviews, and leadership governance meetings.
• Collaborate with other departments to investigate and resolve technical and manufacturing challenges, including equipment malfunctions, process deviations, product quality concerns, and execution barriers.
• Contribute to improvements in NPI and Tech Transfer processes, tools, templates, and best practices, including improvements to process flow, safety, product quality, and production efficiency.
• Support manufacturing operations through routine floor presence, process observation, and partnership with technicians and manufacturing leadership to ensure materials, equipment, procedures, and resources are available.
• Serve as a Manufacturing SME in reviews of deviations, CAPAs, assessments, investigations, and related documentation, providing guidance on processes, procedures, and remediation strategies.
• Author, revise, and maintain SOPs, work instructions, and other manufacturing documentation.
• Support timely initiation, investigation, documentation, and closure of deviations, assessments, investigations, and CAPAs.
• Collaborate with manufacturing leadership to support procurement and availability of production materials, supplies, equipment, and other resources.
• Maintain required training and qualifications in accordance with company and regulatory requirements.
• 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.
• 401K program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED