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:
- 7+ years of final product manufacturing experience with 4+ years within the Pharma/Biotech Industry.
- Familiar with distribution testing per ASTM D4169, International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP).
- Strong knowledge of primary and secondary packaging systems and material science (common materials used in healthcare packaging).
- Material knowledge of structural components is integral in the day-to-day oversight of this role: labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.
- Experience building, modifying, and approving engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications.
- Strong organizational, project management, technical problem-solving, and communication (written and verbal) skills.
- Ability to work in teams and adapt to continuously evolving environments.
- Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Ability to work independently with demonstrated skills in leading project teams.
- Experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.
Responsibilities:
- 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:
- Doctorate OR Masters + 2 years of Engineering experience OR bachelor’s in engineering + 4 years of Engineering experience.