Process Development Engineer (Regulated Industry)

Job Description

Job Description

Job Title: Process Development Engineer

Location: Puerto Rico

Position Type: Onsite Contract Opportunity (ProQuality Network)

Open Positions: 1

Position Overview

Our client is seeking a Process Development Engineer to support manufacturing and process development activities within a production environment. This role focuses on optimizing processes, troubleshooting equipment, and ensuring production and quality targets are consistently achieved.

Key Responsibilities

• Support daily manufacturing operations and continuous improvement initiatives.
• Troubleshoot equipment and processes to resolve issues impacting product quality, yield, or performance.
• Conduct root cause analysis and evaluate non-conforming products.
• Execute technical activities to develop new or improved products and processes for current and next-generation programs.
• Prepare technical reports and deliver presentations to communicate findings and recommendations.
• Apply engineering principles and innovative problem-solving techniques to address complex challenges.
• Collaborate with cross-functional teams and build internal/external partnerships to meet project objectives.
• Participate in project teams to drive completion of key milestones and deliverables.
• Support process and equipment validation activities, including IQ, OQ, and PQ.
• Contribute to Process Performance Qualification (PPQ) efforts and develop validation master plans for new processes or products.
• Assist in qualifying new processes, including development of statistical sampling plans and related procedures.
• Generate and maintain manufacturing instructions for newly developed processes.

Quality System Responsibilities

• Demonstrate a strong commitment to patient safety and product quality at all times.
• Ensure compliance with all applicable quality policies, procedures, and regulatory requirements.
• Support the maintenance of adequate resources (personnel, tools, and systems) to ensure Quality System compliance.
• Promote and contribute to a work environment aligned with quality standards and continuous improvement.

If you meet the qualifications and are interested in this opportunity, we invite you to apply through the job description link and submit your most updated resume.