Job Description

About Us

TPPCDMO San Diego is a growing pharmaceutical CDMO specializing in 503B sterile manufacturing, diagnostic test kit assembly, and high-quality pharmaceutical solutions. We are expanding operations and seeking a Facilities Engineer / Quality Assurance (QA) Specialist to join our team and support our state-of-the-art facility.

Position Overview

This is a hybrid role combining facilities engineering oversight with quality assurance support to ensure our facility remains in compliance with FDA regulations, cGMP standards, and California Board of Pharmacy requirements. The ideal candidate will have a strong understanding of HVAC/cleanroom systems and quality operations within a sterile manufacturing environment.

Key Responsibilities

• Oversee routine maintenance and performance of critical systems (HVAC, WFI, compressed air, cleanrooms).
• Manage facility validation activities (IQ/OQ/PQ) and coordinate with third-party vendors.
• Maintain documentation for equipment calibration, utility monitoring, and maintenance logs.
• Support expansion projects and layout changes in alignment with regulatory compliance.
• Assist with investigations, deviations, CAPAs, and change controls related to facility and equipment.
• Support environmental monitoring program and coordinate corrective actions.
• Participate in audits (internal/external) and regulatory inspections.
• Review and revise SOPs related to facility and QA functions.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in a pharmaceutical or biotech manufacturing environment.
• Strong knowledge of FDA 21 CFR Part 210/211, cGMP, and aseptic processing requirements.
• Experience in cleanroom maintenance, utility systems, and QA documentation.
• Strong interpersonal, documentation, and communication skills.

Preferred

• Experience with 503B compounding or sterile fill-finish facilities.
• Familiarity with EMA, USP <797> , <800> , or ISO 14644 standards

What We Offer

• Competitive salary and benefits.
• Collaborative work environment in a growth-stage company.
• Hands-on impact in building and maintaining a compliant, efficient facility.

Apply Today

If you're a detail-oriented engineer with a passion for pharmaceutical quality, we invite you to join our mission at TPPCDMO San Diego. Submit your application via LinkedIn or email us directly at [email protected]

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