Head of Engineering & Facilities, cGMP Readiness (Startup)

20bloc Inc.; Thousand Oaks (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health, dental, vision and life保险

401(k)

Paid time off

Job summary

20bloc, Inc. is building a cGMP manufacturing space in Thousand Oaks, CA, and seeks a hands-on Head of Engineering and Facilities to lead validation, CQV, and transfer of processes into the facility. You will own critical building systems and support MSAT transitions.

Ideal candidate has 10+ years in biopharma, strong CQV leadership, and ability to work across process development, manufacturing, quality and engineering in a fast-paced startup.

Qualifications

• Bachelor’s degree in engineering field with 10+ years biopharma experience.
• Deep knowledge of cGMP, CQV, and facility qualification.
• Experience leading CQV and site readiness in regulated environments.
• Hands-on troubleshooting and repair skills in lab/production.
• Excellent communication across cross-functional teams.

Responsibilities

• Lead CQV, Facilities, and Site Readiness.
• Support/lead CQV team in protocols for 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.

Skills

Interpersonal communication

Hands-on troubleshooting

Startup environment experience

Project planning

Cross-functional collaboration

Education

Bachelor’s degree in chemical engineering/bioprocess/biochemical engineering

Master’s degree in chemical/bioprocess/biochemical engineering

Tools

Microsoft Office

Job description

20bloc, Inc. is building a cGMP manufacturing space in Thousand Oaks, CA, and seeks a hands-on Head of Engineering and Facilities to lead validation, CQV, and transfer of processes into the facility. You will own critical building systems and support MSAT transitions.

Ideal candidate has 10+ years in biopharma, strong CQV leadership, and ability to work across process development, manufacturing, quality and engineering in a fast-paced startup.