[Remote] Process Engineer

Note: The job is a remote job and is open to candidates in USA. Ultimate Solutions is seeking 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, and compliance with FDA and 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 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
• 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 initiatives
• Communicate technical recommendations, project updates, and engineering solutions to management and cross-functional teams
• Lead or support engineering projects from planning through execution and closure
• Coordinate project activities across departments and external vendors
• Track schedules, deliverables, budgets, and technical milestones
• Multi-site project experience is a plus

Skills

• Bachelor's degree in Engineering
• 3–5 years of engineering experience in the Pharmaceutical or Medical Device industry
• Experience supporting engineering operations in a regulated environment
• Strong analytical and problem-solving skills
• Excellent organization and attention to detail
• Ability to work independently with minimal supervision
• Strong interpersonal, leadership, and communication skills
• Ability to work effectively with cross-functional teams
• Fully bilingual in English and Spanish
• Multi-site project experience is a plus

Company Overview

Company H1B Sponsorship