Onsite Pharma Capital Projects Engineer (GMP/CQV)

Inteldot; Puerto Rico; Hybrid; USD 85.000 - 105.000; Vollzeit

Zusammenfassung

Inteldot is seeking a Project Engineer to support planning, design, and execution of capital projects in a regulated pharmaceutical manufacturing environment. The role collaborates with cross-functional teams, contractors, and vendors to ensure GMP, safety, and quality standards are met.

Applicants should have a Bachelor’s degree in engineering and at least 3 years of experience in pharmaceutical capital projects, with proficiency in both Spanish and English.

Qualifikationen

• 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.
• Bilingual (Spanish and English).

Aufgaben

• 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 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.

Kenntnisse

Communication skills

Bilingual (Spanish & English)

Cross-functional collaboration

Ausbildung

Bachelor’s degree in engineering

Jobbeschreibung

Inteldot is seeking a Project Engineer to support planning, design, and execution of capital projects in a regulated pharmaceutical manufacturing environment. The role collaborates with cross-functional teams, contractors, and vendors to ensure GMP, safety, and quality standards are met.

Applicants should have a Bachelor’s degree in engineering and at least 3 years of experience in pharmaceutical capital projects, with proficiency in both Spanish and English.