Head of Engineering and Facilities

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

Who we are:

20bloc, Inc. (www.20bloc.com) 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.

JOB TITLE:

Head of Engineering and Facilities

Position Overview:

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.

Key Responsibilities:

• 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.

Required Qualifications:

• 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 willingness to perform hands‑on support when needed, including minor fixes or repairs to lab, production, or facilities equipment when appropriate.
• Excellent interpersonal and communication skills, with the ability to work effectively with process operators, facilities staff, engineers, quality professionals, executive leadership, consultants, and PhD‑level scientists.
• Proficiency in standard Microsoft Office applications.
• Thrives in a fast‑paced, ambiguous, hands‑on startup environment where priorities can shift quickly and the role may require moving between strategic planning, technical decision‑making, team leadership, CQV execution, facilities support, and urgent troubleshooting within the same day.

Preferred Qualifications:

• Master’s degree in chemical engineering, bioprocess engineering, biochemical engineering, or another relevant engineering or scientific discipline.
• Proven experience managing teams of 5 or more employees, including technical staff, engineers, contractors, consultants, and cross‑functional contributors.
• Direct CQV execution experience for cGMP facilities, utilities, process equipment, analytical equipment, cleanrooms, or supporting GMP infrastructure.
• Experience reviewing engineering drawings, building blueprints, P&IDs, equipment documentation, vendor packages, turnover packages, and qualification documentation.
• Experience working in a startup or early‑stage biopharma environment where hands‑on support, rapid prioritization, and cross‑functional problem solving are required.
• Experience supporting MSAT activities

This is a full‑time, on‑site position located in Thousand Oaks, California, and requires working on‑site Monday through Friday. All applicants must be authorized to work in the United States. We are not sponsoring employment visas.

Compensation: The salary range for this position is $140,000-180,000. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.

We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.