Project Engineer

InteldotGurabo, PR
Onsite

About The Position

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.

Requirements

  • 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).

Nice To Haves

  • 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.

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.
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