Location: Manatí, Puerto Rico
Industry: Pharmaceutical Manufacturing
Technical Focus: Manufacturing or Packaging Technologies
Position SummaryWe are seeking an experienced
Subject Matter Expert (SME) to provide technical expertise in
Automation, Technical Services, and Commissioning & Qualification (C&Q) for pharmaceutical manufacturing or packaging technologies.
The SME will support equipment and system implementation, troubleshooting, qualification, optimization, and lifecycle activities. This role will collaborate with Engineering, Manufacturing, Packaging, Quality, Validation, and external suppliers to ensure reliable operations and compliance with applicable GMP requirements.
Main Responsibilities- Provide technical expertise for manufacturing or packaging equipment, automated systems, and related processes.
- Support automation initiatives, equipment integration, system upgrades, and operational improvements.
- Assess and troubleshoot equipment, process, and control system issues, coordinating corrective actions with the appropriate teams.
- Support technical services activities, including technology transfer, equipment readiness, process improvements, and manufacturing support.
- Develop, review, and execute C&Q documentation, including commissioning plans, risk assessments, and IQ/OQ/PQ protocols, as applicable.
- Develop and review user requirements, technical specifications, acceptance criteria, and equipment documentation.
- Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), startup, and equipment turnover.
- Evaluate equipment and system changes for their impact on product quality, process performance, and the validated state.
- Support deviations, technical investigations, root cause analysis, CAPAs, and change controls.
- Coordinate with equipment vendors, automation integrators, contractors, and cross-functional teams.
- Ensure technical documentation is complete, accurate, and aligned with GMP and site requirements.
- Provide technical guidance and training to engineering and operational personnel.
General Requirements- Strong technical knowledge of pharmaceutical manufacturing or packaging technologies.
- Demonstrated expertise in automation, technical services, and C&Q activities.
- Experience with automated equipment and control systems, including PLCs, HMIs, and SCADA systems, as applicable.
- Working knowledge of GMP requirements, equipment qualification, risk-based approaches, and data integrity principles.
- Ability to interpret engineering drawings, control narratives, equipment specifications, and technical documentation.
- Strong troubleshooting, root cause analysis, and technical writing skills.
- Ability to coordinate multidisciplinary teams and manage multiple technical priorities.
- Strong written and verbal communication skills in English and Spanish.
- Availability to work on-site in Manatí, Puerto Rico.
Education and Experience Requirements- Bachelor's degree in Electrical, Mechanical, Chemical, Industrial, or Computer Engineering, or a related technical discipline.
- Minimum of seven (5) years of relevant experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
- Demonstrated experience supporting manufacturing or packaging equipment throughout implementation, qualification, and routine operation.
- Hands-on experience with commissioning, qualification, equipment startup, and technical troubleshooting.
- Experience supporting automation projects, technology transfers, or equipment upgrades.
- Previous experience serving as a technical lead or subject matter expert is preferred.
- Familiarity with computerized system validation and electronic validation platforms is preferred.
