Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Employment type: Full time and onsite role
Role Summary
The Project Engineer supports the planning, design, and execution of capital projects within a regulated pharmaceutical manufacturing environment. This role provides technical engineering support across manufacturing, packaging, equipment, and facility-related projects in both synthetic and biotherapeutic operations. The Project Engineer works closely with cross-functional teams, contractors, and vendors to ensure successful delivery of engineering solutions in compliance with GMP, safety, and quality standards.
Key Responsibilities
- Support the execution of capital projects through technical engineering input and coordination.
- Assist with technical design development, engineering deliverables, and design reviews.
- Review and manage design change requests in alignment with project requirements and quality standards.
- Liaise with engineering contractors, equipment vendors, and internal technical Subject Matter Experts (SMEs).
- Support development of basis-of-design (BOD) documents and technical specifications.
- Participate in installation, commissioning, and qualification activities for manufacturing and packaging systems.
- Support punch-list development, tracking, and resolution during project execution and closeout.
- Ensure engineering deliverables comply with GMP, safety, and regulatory requirements.
- Assist in troubleshooting technical issues and supporting project execution timelines.
Requirements & Qualifications
- Bachelor's degree in engineering (Mechanical, Chemical, Electrical, or related field).
- Minimum 3 years of experience managing or supporting capital projects in the pharmaceutical industry.
- Experience in manufacturing and packaging processes and equipment, including synthetic and/or biotherapeutic operations.
- Familiarity with GMP environments and regulated project execution.
- Experience working with engineering design documentation, specifications, and construction/installation support.
- Strong communication skills with ability to work across contractors, vendors, and internal teams.
- Ability to support technical problem-solving and coordinate multiple stakeholders.
- Bilingual (Spanish and English).
Preferred Qualifications
- Experience supporting commissioning, qualification, and validation (CQV) activities.
- Familiarity with cleanroom environments, pharmaceutical utilities, or process systems.
- Exposure to design change control processes in regulated environments.
- Understanding of project lifecycle from design through installation and startup.