The posting
Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift (8:00 AM – 5:00 PM)
Job Description:
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Requirements & Qualifications:
- Experience supporting manufacturing process and operations in a GxP/GMP environment, with a solid understanding of process performance, equipment, and manufacturing workflows.
- Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
- Experience supporting controlled document and process changes, including document updates, coordination of reviews and approvals, implementation activities, and associated GMP documentation.
- Experience supporting Continuous Process Verification (CPV) activities, including process data review, evaluation of process performance and variability, identification of trends, preparation of periodic CPV reports and presentations, and escalation of potential process performance issues.
- Ability to interpret manufacturing and process data to support process monitoring, investigations, troubleshooting, and continuous improvement activities.
- Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
- Ability to perform system configuration activities, including understanding business and process requirements, evaluating configuration needs, implementing, or supporting configuration changes, testing changes, documenting results, and troubleshooting system or process issues.
- Experience working with controlled documentation, data integrity requirements, and GMP systems, and change management processes.
- Familiarity with SQL for data querying, troubleshooting, data verification, and investigation of system or process-related issues is preferred.
- Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities is considered a plus.
- Familiarity with tools such as Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies is considered a plus.
- Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations, is preferred.
- Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities is considered a strong plus.
- Strong engineering, analytical and technical problem-solving skills, with the ability to evaluate manufacturing, process and system issues and identify practical solutions.
- Excellent written and verbal communication skills, with the ability to interact effectively across different communication and working styles.
- Fully bilingual in English and Spanish.
Responsibilities:
- Support manufacturing/process engineering activities, system configuration, and support (including DME and PLM), CPV activities, controlled documentation, and manufacturing process monitoring.
- Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
- Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
- Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
- Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
- Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
- Implementing engineering controls and completing actions associated with safety incidents and INCA records.
- Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
- Working with biopharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.
- Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
- Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
- Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs.
Education:
- Bachelor degree in Engineering, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
