Project Engineer

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.

• →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.

• 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).

• 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.