Ultimate Solutions
Posted 58 days agoVerified live 1d ago
Process Engineer
Brief overview
Remote
UndergradOr in progress
3+ yrsMinimum
Process ImprovementEquipment QualificationValidationNew Product IntroductionTechnology TransferManufacturing Process DesignRoot Cause AnalysisStatistical ToolsEngineering ToolsFDA ComplianceGMP ComplianceISO Standards ComplianceChange ControlCAPARisk AssessmentProject Management
About the company
Ultimate Solutionsuscglobal.com
Ultimate Solutions provides industrial automation, serialization, regulatory compliance, and packaging solutions for the life sciences.
Job description
Summary
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
Qualifications
Must Haves
- 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
Nice to Haves
- Multi-site project experience is a plus
