Head of Engineering and Facilities

Who we are:

20bloc, Inc. () is an early-stage biopharma company creating breakthrough protein-based drugs. We are developing a hemoglobin-based oxygen carrier for first response, organ preservation, and oxygen therapy. We value innovations through hard work and quality intellectual exchange. We are collaborative. We are intellectual. We are hands-on.

We are seeking an experienced, hands-on Head of Engineering and Facilities to lead the validation efforts and launch the facility management program. This is a critical startup role for 20bloc as the company completes construction of its cGMP manufacturing space, qualifies critical building systems and cGMP infrastructure. The Head of Engineering and Facilities will own transfer of our processes and equipment into the cGMP facility, establish manufacturing readiness, and serve as the primary technical owner of equipment qualification.

The role also provides support to the MSAT function currently being performed by outside experts. The ideal candidate thrives in a fast-paced, dynamic startup environment, communicates effectively with operators, engineers, quality professionals, and PhD scientists, and is equally comfortable developing strategic technical plans, managing schedules, troubleshooting facility or equipment issues, and rolling up their sleeves to make minor fixes when needed.

• Lead CQV, Facilities, and Site Readiness
• Support/lead the CQV team in developing and executing protocols for critical building systems, cGMP infrastructure, utilities, process equipment, and R&D equipment.
• Support commissioning and qualification planning, protocol generation, execution readiness, field execution, deviation resolution, and final documentation review.
• Support/facilitate review of CQV documentation, system boundaries, turnover packages, traceability, and acceptance criteria for cGMP use and inspection readiness.
• Lead integrated planning for Shakedown readiness and execution, EMPQ, APS, equipment qualification, and transition to routine operations.
• Take ownership of critical facility systems including HVAC, backup generator, UPS, DI water, domestic hot and cold water, boiler, vacuum, clean and dry compressed air, electrical systems, and related utilities in conjunction with the engineering team.
• Provide practical, hands-on troubleshooting of minor lab, production, or facilities equipment issues when appropriate.
• Support/facilitate technology transfer of the drug substance and drug product processes into the cGMP facility, including batch record and SOP development, and manufacturing readiness.
• Facilitate teams working as technical bridge between process development, manufacturing, quality, analytics, R&D, engineering, facilities, and external scientific advisors or consultants.
• Develop practical, phase-appropriate technical plans and schedules that support clinical manufacturing, cGMP readiness, and long-term scalability.
• Support the MSAT function as 20bloc transitions into cGMP clinical manufacturing operations.

• Bachelor’s degree in chemical engineering, bioprocess engineering, biochemical engineering, or another engineering field required.
• 10 or more years of professional experience in biopharma, biotech, pharmaceutical manufacturing, technical operations, CQV, engineering, facilities, or related regulated environments.
• Deep working knowledge of cGMP requirements, CQV execution, facility and utility qualification, equipment qualification, GMP documentation, and inspection readiness.
• Demonstrated ability to develop project plans, execution schedules, resource plans, and practical work plans for complex biopharma projects.
• Mechanical aptitude and…