We are looking for a motivated Process Engineer to support engineering activities in a regulated Pharmaceutical or Medical Device environment. This role will focus on process improvement, equipment qualification, validation, continuous improvement, and new product introductions while ensuring compliance with FDA, GMP, ISO, and company quality requirements.

Key Responsibilities

*Process Engineering*
- Lead or support engineering projects, including new product introductions, technology transfers, and process improvements.
- Design, document, implement, and optimize manufacturing processes.
- Analyze yield, OEE, cycle time, downtime, and productivity data to identify improvement opportunities.
- Perform root cause analysis and support effective corrective and preventive actions.
- Develop and revise procedures, work instructions, specifications, and process standards.
- Use statistical and engineering tools to support data-driven decisions.
- Coordinate activities with operations, suppliers, equipment manufacturers, and cross-functional teams.

*Validation and Qualification*




- Develop validation strategies for equipment, systems, utilities, and manufacturing processes.
- Create, execute, review, and approve validation documentation, including IQ, OQ, PQ, Process Validation, Equipment Qualification, Test Method Validation, and Component Qualification.
- Prepare validation protocols, reports, summaries, and related technical documents.
- Coordinate qualification activities in line with regulatory requirements and company procedures.
- Support equipment commissioning, startup, and qualification activities.

*Compliance and Quality*
- Ensure compliance with FDA regulations, GMP requirements, ISO standards, and company quality systems.
- Review and approve engineering and validation documentation.
- Prepare technical documentation for process improvements, equipment changes, and new technology implementation.
- Support Change Control, Deviations, CAPA, Risk Assessments,

📌 Process Engineer (Puerto Rico)
🏢 Ultimate Solutions
📍 Puerto Rico