Technical Engineering Specialist – Pharmaceutical Manufacturing
Job Type: Full-Time
Location: Carolina, PR
Industry: Pharmaceutical / Biotechnology / Medical Device Manufacturing
Position Overview
We are seeking an experienced Technical Engineering Specialist to provide technical engineering, maintenance, compliance, and equipment optimization support within a regulated pharmaceutical manufacturing environment.
The successful candidate will serve as a technical resource for maintenance and engineering teams, supporting utility systems, process equipment, instrumentation, calibration, electrical systems, technical cleaning, validation, and manufacturing systems. This role will be responsible for ensuring maintenance activities and engineering practices remain compliant with cGxP requirements, FDA regulations, corporate policies, and applicable industry standards.
Strong experience with Maximo and SAP, combined with pharmaceutical manufacturing experience and English/Spanish bilingual capability, is essential for success in this position.
Key Responsibilities
- Provide technical engineering support for system and equipment optimization, upgrades, replacements, modifications, and continuous improvement initiatives.
- Ensure utility systems, process equipment, instrumentation, calibration, electrical systems, and technical cleaning systems are maintained in compliance with applicable cGxP, FDA, regulatory, and industry requirements.
- Provide technical guidance to maintenance teams regarding engineering, regulatory, compliance, calibration, quality, validation, environmental monitoring, microbial, electrical, and process maintenance issues.
- Support the development, implementation, and standardization of maintenance training programs, SOPs, equipment procedures, and operational standards.
- Provide technical support during FDA and other regulatory agency inspections, including preparation of documentation and responses to regulatory observations or inquiries.
- Support investigations associated with high-purity water systems, environmental monitoring, utility systems, equipment, and maintenance-related alert/action notifications.
- Assist with investigation activities, root-cause analysis, corrective actions, and preventive actions associated with maintenance and engineering issues.
- Develop and maintain an audit program for maintenance activities and conduct routine audits of documentation, operations, equipment, and related areas to ensure continued regulatory compliance.
- Partner with Plant Engineering and other cross-functional teams to evaluate and implement engineering improvements, compliance initiatives, policy changes, equipment upgrades, and optimization programs.
- Evaluate existing sanitization, maintenance, and technical cleaning procedures and recommend improvements where appropriate.
- Recommend procedural, equipment, process, and system changes to department leadership.
- Propose modifications and improvements to process systems, utility systems, cleanroom systems, and manufacturing equipment in coordination with Plant Engineering.
- Review and support validation protocols and documentation associated with equipment, utilities, processes, and engineering systems.
- Provide technical writing support for SOPs, investigations, engineering documentation, protocols, reports, and other controlled documents.
- Collaborate with Maintenance, Engineering, Quality, Validation, Manufacturing, Environmental Monitoring, and other cross-functional teams to resolve technical and compliance issues.
- Support project management activities associated with engineering improvements, equipment modifications, compliance initiatives, and facility optimization.
- Ensure engineering and maintenance activities remain aligned with applicable FDA requirements, regulatory guidance, corporate standards, and site procedures.
- Participate in extended-hour activities, including weekends and holidays, when required to support manufacturing operations or critical engineering activities.
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical field.
- Minimum 5 years of engineering experience within the pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing industry.
- Candidates with a Master's degree and 3+ years of relevant engineering experience may also be considered.
- Direct experience supporting pharmaceutical manufacturing or process/manufacturing areas.
- Strong working knowledge of cGxP requirements and regulatory guidance, including their practical application within a regulated manufacturing environment.
- Demonstrated experience with IBM Maximo and SAP — strong proficiency in both systems is highly preferred/required.
- Experience with maintenance management, engineering systems, equipment documentation, work management, and compliance processes.
- Strong understanding of equipment and utility systems, maintenance, instrumentation, calibration, electrical systems, and technical cleaning.
- Experience with validation protocols and validation requirements.
- Strong technical writing and investigation skills.
- Demonstrated analytical and problem-solving capabilities.
- Experience supporting FDA or other regulatory inspections is highly desirable.
- Strong project management and organizational skills.
- Excellent verbal and written communication skills.
- Fluent in both English and Spanish, with strong professional oral communication skills.
- Proficiency with Microsoft Windows and Microsoft Office applications.
- Strong leadership, collaboration, and team-building skills.
- Ability to work extended hours, including weekends and holidays, when business needs require.
Pay: $26.50 - $34.89 per hour
Work Location: In person
