Project Engineer

Summary

Pinnaql, through Validation & Engineering Group, provides engineering and technical services to regulated pharmaceutical, biotechnology, chemical, food, and medical device industries. The Project Engineer will support capital projects and technical initiatives across manufacturing systems, equipment, facilities, utilities, cleanrooms, and other regulated operational systems, coordinating engineering deliverables, installation, commissioning, startup, and operational handover.

Responsibilities

• Support engineering and technical execution activities throughout the project lifecycle from planning through startup and operational handover
• Coordinate engineering deliverables, technical reviews, design changes, and project implementation activities
• Support development and review of engineering documentation including technical specifications, drawings, calculations, change requests, project records, and turnover documentation
• Coordinate with equipment vendors, contractors, engineering firms, and internal stakeholders to support project execution activities
• Support installation activities, field coordination, startup readiness, commissioning support, and punch-list resolution
• Participate in project meetings and provide technical updates, action item follow-up, risk identification, and status reporting
• Assist with project planning, scheduling, procurement coordination, and tracking of technical deliverables
• Support troubleshooting and resolution of technical issues impacting project execution, commissioning activities, or operational readiness
• Support equipment startup, turnover, and field implementation activities as required
• Support execution of engineering activities in accordance with applicable GMP, safety, environmental, and site requirements
• Support safe execution of project activities in alignment with site EHSS requirements and procedures
• Support continuous improvement initiatives related to engineering execution, operational performance, and project delivery

Skills

• Bachelor's degree in Engineering required
• Minimum of 3 years of experience supporting capital projects within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries
• Experience supporting manufacturing systems, packaging equipment, facilities, utilities, process equipment, cleanroom environments, or regulated operational systems
• Experience supporting engineering projects through design, procurement, installation, startup, commissioning support, qualification support, or operational handover phases
• Familiarity with technical documentation, change management, engineering coordination, and project execution practices in GMP-regulated environments
• Experience coordinating with contractors, vendors, engineering firms, and cross-functional technical teams
• Excellent verbal and written communication skills in both English and Spanish, including technical writing, documentation preparation, and communication of technical deliverables
• Strong organizational, analytical, troubleshooting, and problem-solving skills with the ability to manage multiple priorities in fast-paced environments
• Ability to work on-site in the eastern region of Puerto Rico
• Ability to work effectively within fast-paced and highly regulated environments
• Familiarity with commissioning, startup, FAT activities, equipment implementation, or operational readiness activities is preferred
• Experience with engineering and project coordination tools such as AutoCAD, SAP, MS Project, Bluebeam, or similar systems is preferred

Qualifications

Must Haves

• Bachelor's degree in Engineering required
• Minimum of 3 years of experience supporting capital projects within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries
• Experience supporting manufacturing systems, packaging equipment, facilities, utilities, process equipment, cleanroom environments, or regulated operational systems
• Experience supporting engineering projects through design, procurement, installation, startup, commissioning support, qualification support, or operational handover phases
• Familiarity with technical documentation, change management, engineering coordination, and project execution practices in GMP-regulated environments
• Experience coordinating with contractors, vendors, engineering firms, and cross-functional technical teams
• Excellent verbal and written communication skills in both English and Spanish, including technical writing, documentation preparation, and communication of technical deliverables
• Strong organizational, analytical, troubleshooting, and problem-solving skills with the ability to manage multiple priorities in fast-paced environments
• Ability to work on-site in the eastern region of Puerto Rico
• Ability to work effectively within fast-paced and highly regulated environments

Nice to Haves

• Familiarity with commissioning, startup, FAT activities, equipment implementation, or operational readiness activities is preferred
• Experience with engineering and project coordination tools such as AutoCAD, SAP, MS Project, Bluebeam, or similar systems is preferred