Summary:
We are seeking an experienced Sr. Manufacturing Engineer – Computer Systems Validation (CSV) to support manufacturing operations in a regulated environment. This role is responsible for supporting IT system upgrades associated with manufacturing equipment, executing Computer System Validation (CSV) activities, and maintaining compliant validation documentation throughout the system lifecycle. The selected candidate will work closely with Manufacturing, Engineering, Quality, Validation, and Information Technology teams to ensure manufacturing systems remain compliant and operational.

Key Responsibilities:

• Support IT system upgrades related to manufacturing equipment.
• Execute Computer System Validation (CSV) activities in accordance with company procedures and regulatory requirements.
• Develop, review, and maintain validation protocols, reports, and technical documentation.
• Update manufacturing system documentation as required during system modifications and upgrades.
• Coordinate and execute testing activities for manufacturing-related computerized systems.
• Support integrations between manufacturing equipment and IT applications.
• Assist with system implementation, troubleshooting, and validation activities.
• Collaborate with cross-functional teams to ensure project milestones and validation deliverables are achieved.
• Ensure compliance with applicable quality systems, validation standards, and regulatory requirements.

Minimum Qualifications:

• Bachelor's degree in Engineering, Computer Engineering, Computer Science, Information Systems, or a related technical discipline.
• Minimum of 5 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, biotechnology, or similar).
• Hands-on experience performing Computer System Validation (CSV).
• Experience supporting manufacturing IT systems and integrations with manufacturing equipment.
• Experience supporting computerized system upgrades and implementation projects.
• Strong technical writing and documentation skills.
• Excellent analytical, troubleshooting, and problem-solving abilities.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Bilingual (English and Spanish) preferred.

Preferred Qualifications

• Experience in FDA-regulated, cGMP, medical device, pharmaceutical, or biotechnology manufacturing.
• Knowledge of GAMP 5, 21 CFR Part 11, Computerized System Lifecycle (CSLC), and Change Control processes.
• Experience validating manufacturing software and computerized equipment systems.

Additional Requirements

• Available to work overtime and weekends as required to support project schedules.
• Strong organizational, communication, and interpersonal skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Work Methodology

• 100% on site job
• Full on-site job in Juncos, PR
• Administrative shift
• Duration: 6 months (1st contract) with a high possibility of extension based on performance and budget.
• Type of industry: Medical devices
• Expected hiring month: July 2026