We are looking for 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, continuous improvement, and new product introductions while ensuring compliance with FDA, GMP, ISO, and company quality requirements.
Key Responsibilities
Process Engineering
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.
Validation and Qualification
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.
Compliance and Quality
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.
Project Management
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.
Minimum Qualifications
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.
Professional Competencies
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.
Ultimate Solutions Corp. is an Equal Opportunity Employer committed to creating an inclusive workplace where all employees are valued and respected.
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Ultimate Solutions combines regulatory expertise, cutting-edge technology, and operational excellence to deliver tailored 360° solutions at every stage of your pharmaceutical, biotech, or medical device projects. With seven specialized business units and presence in Puerto Rico, USA, and Spain, our seamless approach drives efficiency, compliance, and innovation at every step. As your strategic partner, we transform processes to improve lives through innovation, unwavering commitment, and a global vision.
