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. This role will focus on process improvement, equipment qualification, validation, and ensuring compliance with FDA, GMP, ISO, 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