Automation Engineer | CSV | Pharmaceutical | Part-Time

LOCATION: Manatí, Puerto Rico

We are seeking a CSV / Automation Engineer to support pharmaceutical projects in Manatí, Puerto Rico. The engineer will support Computerized System Validation (CSV), automation, commissioning, qualification, system assessments, requirements development, technical documentation, and lifecycle activities for pharmaceutical manufacturing systems and equipment.

The ideal candidate will have hands-on experience in CSV, automation, computerized systems, pharmaceutical manufacturing, system impact assessments, requirements and design specifications, data integrity, and validation documentation. Experience with commissioning and qualification of pharmaceutical equipment, particularly autoclaves, is highly preferred.

This is a part-time, contract-based opportunity for an independent professional willing to work on-site in Manatí, Puerto Rico.

Main Responsibilities

• Support CSV and automation activities for pharmaceutical manufacturing systems and computerized equipment.

• Perform System Level Impact Assessments and support system classification and validation strategies.

• Develop and/or review System Requirements, Functional Specifications, and Software Design Specifications.

• Develop and maintain Traceability Matrices linking requirements, specifications, testing, and validation deliverables.

• Perform or support Data Integrity Risk Assessments for computerized systems.

• Develop and/or review Hardware Design Specifications for automation and computerized systems.

• Perform or support Parameters and Alarms Criticality Assessments.

• Develop, review, and execute validation and testing documentation, including electronic protocols and test scripts.

• Support commissioning, qualification, validation, and startup activities for pharmaceutical equipment and computerized systems.

• Support Commissioning and Qualification of autoclaves, including protocol execution, testing, documentation, and resolution of discrepancies.

• Support system modifications, upgrades, troubleshooting, requalification, and lifecycle activities.

• Support decommissioning activities for pharmaceutical equipment and systems, including Injection Measuring Systems, Balances, Glass Dryers, and Glass Washers.

• Support deviations, Change Controls, CAPA, investigations, and discrepancy resolution related to CSV and automation activities.

• Ensure validation and automation activities comply with cGMP, FDA requirements, data integrity principles, and company procedures.

• Prepare and maintain validation packages, technical reports, protocols, specifications, risk assessments, and other project documentation.

• Collaborate with Quality, Validation, Engineering, Automation, Manufacturing, Facilities, Utilities, C&Q, IT, and vendors throughout project execution.

General Requirements

• Fluent in Spanish and English, spoken and written.

• Proficiency in Microsoft Office 365, including Word, Excel, PowerPoint, Teams, and SharePoint.

• Strong technical writing and documentation skills in English.

• Strong understanding of cGMP, FDA requirements, CSV, automation, and computerized systems.

• Strong understanding of data integrity principles and risk-based validation approaches.

• Excellent attention to detail and quality mindset.

• Strong analytical and problem-solving skills.

• Effective communication and collaboration skills.

• Ability to work independently and manage priorities in a pharmaceutical manufacturing environment.

• Ability to work part-time and on-site in Manatí, Puerto Rico.

Education Requirements

• Bachelor’s Degree in Engineering, Computer Science, Information Technology, Automation, Electrical Engineering, or a related field.

Experience Requirements

• Minimum of 5 years of experience in CSV, Automation, Validation, Controls, Engineering, or related pharmaceutical projects.

• Experience working in pharmaceutical manufacturing or other FDA-regulated environments.

• Hands-on experience with Computerized System Validation (CSV) and validation lifecycle activities.

• Experience with System Level Impact Assessments, System Requirements, Functional Specifications, Software Design Specifications, and Traceability Matrices.

• Experience with Data Integrity Risk Assessments.

• Experience developing or reviewing Hardware Design Specifications.

• Experience performing Parameters and Alarms Criticality Assessments.

• Experience with commissioning and qualification of pharmaceutical equipment, particularly autoclaves, is highly preferred.

• Experience with decommissioning of pharmaceutical equipment, preferably including Injection Measuring Systems, Balances, Glass Dryers, and Glass Washers.

• Experience with electronic protocols, electronic test execution, or electronic validation/lifecycle management systems such as ALM or similar platforms is preferred.

• Experience with automation, control systems, PLCs, SCADA, DCS, BAS, or other computerized manufacturing systems is a plus.

• Experience supporting deviations, Change Controls, CAPA, investigations, and discrepancy resolution.

• Experience working with cross-functional teams including Quality, Validation, Engineering, Automation, Manufacturing, IT, Facilities, and vendors.

Physical Requirements

• Ability to sit for extended periods.

• Light physical activity may occasionally be required.

• Must be able to visit field locations and manufacturing areas as needed.

• Must be able to wear personal protective equipment (PPE) when required.

• Ability to work in industrial and pharmaceutical manufacturing environments.

• Ability to work on-site in Manatí, Puerto Rico on a part-time basis.