Ultimate Solutions · 4 days ago
Process Engineer
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, continuous improvement, new product introductions, compliance, and project management.
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H1B Sponsor Likely
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
Qualification
Required
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
Preferred
Multi-site project experience is a plus
Company
Ultimate Solutions
Packaging industrial automation and compliance for life sciences.
H1B Sponsorship
Ultimate Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
93%
Represents job field similar to this job
Engineering and Development
Management and Executive
Trends of Total Sponsorships
*2024 (1)
2022 (45)
Funding
Current Stage
Growth StageLeadership Team
Yoel Rivera
President/CEO
Company data provided by crunchbase