Support planning, design, and execution of capital projects in a regulated pharmaceutical manufacturing environment. Provide technical engineering input across manufacturing, packaging, equipment, and facility projects; assist with design development, change requests, BODs, commissioning/qualification, installation, troubleshooting, and ensuring compliance with GMP, safety, and quality standards while coordinating contractors, vendors, and internal SMEs.
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.
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