Job Function:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Anasco, Puerto Rico, United States of America

Job Description:

The Engineer plans, schedules, and executes moderately complex engineering activities and projects within an assigned manufacturing value stream and/or technical function (e.g., Process, Packaging, Materials/Supplier, Equipment/Validation). The role provides technical leadership to improve safety, quality, delivery, and cost, and supports new product introductions, product/process changes, and compliance commitments in a regulated (GMP/ISO/FDA) environment.

The Engineer leads and/or supports change control, equipment/process/packaging qualification and validation activities (IQ/OQ/PQ as applicable), technical investigations, and continuous improvement initiatives. The role interfaces directly with cross-functional partners (Operations, Quality, Engineering, Supply Chain, and external vendors) to deliver business objectives and ensure robust, compliant solutions.

1. Project Delivery & Technical Leadership
• Plans and executes moderately complex engineering and/or change control projects requiring conceptual evaluation, design, and validation.
• Applies standard project management methodologies to plan work, manage scope, and deliver milestones.
• Participates in technical design reviews and translates requirements into manufacturing, product, or equipment specifications.
• Supports capital and expense project justification as applicable.

2. Qualification, Validation & Change Control
• Plans and executes qualification of new or modified equipment, controls, systems, and/or processes; supports vendor and site acceptance testing as required.
• Leads and/or supports validation activities (IQ/OQ/PQ), protocol execution, and reporting.
• Authors and reviews technical documentation in accordance with GDP and internal standards.

3. Process / Equipment / Packaging / Materials Improvements
• Identifies and implements equipment, process, packaging, and/or materials enhancements to improve efficiency, yield, reliability, and safety.
• Designs and executes experiments and characterization studies using statistical tools (e.g., DOE, capability, stability, trending).
• Supports packaging or materials qualification activities where applicable.

4. Troubleshooting, Investigations & CAPA Support
• Performs structured problem solving and root cause analysis for deviations, nonconformances, audit actions, and CAPAs.
• Partners with Operations to address downtime, rejects, and performance issues.
• Provides training and technical support to operations and engineering personnel as appropriate.

5. Compliance, Risk & Continuous Improvement
• Ensures compliance with applicable GMP, ISO, FDA, and company requirements.
• Participates in risk assessments and continuous improvement initiatives.
• Maintains the highest standards of professionalism, ethics, and compliance.

Qualifications:
• Bachelor's degree in Engineering is required.
• A minimum of 2 years of related experience is required.
• Demonstrated project execution experience.
• Experience in ISO/FDA regulated environments is preferred.
• Experience with qualification, validation, and change control activities is preferred.
• Exposure to Lean, Six Sigma, or structured problem-solving methodologies is preferred.

Required Skills:

Preferred Skills:
Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy