Process Engineer

About the role

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

Responsibilities

• 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 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.
• 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.
• 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, and continuous improvement.

Datos clave

• The role supports engineering activities in a regulated Pharmaceutical or Medical Device environment.
• Key areas include process improvement, equipment qualification, validation, and new product introductions.
• The role supports compliance with FDA, GMP, ISO, and company quality requirements.