Job Description
Job Description
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Project Engineer
Position Summary
The Project Engineer will support the execution of capital projects and technical initiatives within regulated pharmaceutical and biotechnology manufacturing environments. This role is responsible for coordinating and supporting engineering activities associated with manufacturing systems, packaging equipment, process improvements, facilities, utilities, cleanroom environments, and other regulated operational systems.
Projects may include equipment installations, facility upgrades, utilities modifications, operational readiness initiatives, commissioning support, process improvements, and technical implementation activities supporting manufacturing and engineering operations.
The role requires strong technical coordination, problem-solving, and cross-functional collaboration with Engineering, Operations, Quality, EHSS, Procurement, Construction, contractors, and equipment vendors to support successful project execution.
Key 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.
Qualifications & Experience
- 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.
- 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.
- 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.
Additional Requirements
- Ability to work on-site in the eastern region of Puerto Rico.
- Must be eligible to complete client-required onboarding, training, and site access requirements.
- Ability to work effectively within fast-paced and highly regulated environments.
The above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.