Senior Director of Engineering & Facilities Site Start Up

at Sana Biotechnology
Location South San Francisco
Date Posted September 2, 2021

Description

JOB PURPOSESana is seeking a dynamic and experienced engineering leader to provide oversight of a capital project for our first GMP cell and gene therapy facility from engineering design, construction, and through commissioning and qualification. You will be accountable for the successful delivery of the project to the approved schedule and capital budget. This role will support the full project lifecycle from detailed design, implementation, and commissioning/qualification and develop turn over plans to deliver an operational facility. After commissioning, the engineering lead would potentially transition into the head of facilities depending on the selected candidates experience and qualification as well as the success of this project. You will report to the Vice President of Manufacturing.DUTIES AND RESPONSIBILITIES Support the development of the capital engineering strategy to support the Engineering, Procurement, Construction, & Management (EPCM) of the Design, Build, CQV, & Operations of the Facility. Provide oversight of the key project deliverables involving Feasibility, Conceptual Design, Basic Design, Detailed Design, Construction Oversight, CQV, and MFG Operational Readiness. Provide experienced project controls oversight of the capital project through regular review of change requests, schedule, accurate cost and cash flow projections, risk management, project monthly reporting and financial audit preparation. Support the management/ approval of project contracts, budgets, bid assessments, project cashflows, and budget dashboards. Leverage knowledge of the functional requirements of biopharmaceutical facilities and engineering best practices, while ensuring that appropriate internal and external resources are incorporated into the project design and execution. Participate in the execution of project risk assessments. Support the development of the Facility Commissioning and Validation Master Plans for the project including the design, planning, execution, review and final sign-off of CQV protocols. Review P&IDs, perform P&ID walk-downs, assist validation team with IQ, OQ and PQ efforts as required. Identify project gaps and facilitate remediation plans. Partner with the User Team Lead to establish and maintain the projects Master Equipment/ System List. Collaborate with the project manager and external partners to develop the Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3's, Bid Assessments, and Risk Assessments. Apply Quality by Design principles, experience which aligns with FDA, ICH, and ISPE guidelines. Establish facilities contracts to support painting, roof repair, welding, machine shop, electrical, office moves, pest control, security, and janitorial. Establish/ maintain HEPA certification program within an SOP and compliant service contract. Evaluate/ establish facilities, utilities, and HVAC equipment spare parts requirements & systems to ensure required like-for-like spare parts are on hand to support facility uptime. Ensure central utility plant, electrical/ UPS systems, HVAC Systems, and HEPA certifications are maintained per preventative maintenance program. Support asset classification and perform criticality assessments, rating equipment criticality and assigning appropriate maintenance plans based on criticality rating. Develop and integrate Work Plans associated with each piece of equipment to ensure plans will be consistently executed and documented regardless of technician. Partner with manufacturing team to Perform Failure Mode Event Analysis (FMEA) and Root Cause Analysis (RCA) on manufacturing equipment and revision of preventative maintenance SOPs to reflect FMEA findings. Assure that the construction project and the finished facility are compliant with all applicable safety, regulatory, legal requirements. Demonstrate Sana's core values and the attributes that support these core values Lead from every seat - Deliver for patients, act with honesty and integrity, engage in crucial conversations and have humility Thrive as a team - approach work and relationships with curiosity, collaboration, personal connectivity Make it happen - Have an eye for simplification, execution and delivery, resilience, and grit Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines. Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment. Innate ability to assess talent that will help grow the organization and add Sana's culture. QUALIFICATIONS Basic Qualifications 15+ years biopharmaceutical GMP Facilities/ Reliability Centered Maintenance, engineering, or manufacturing experience required. Significant biopharmaceutical construction project management skills and proven experience in managing large capital projects with emphasis on Biopharma and ATMP Projects, as well as site utility and infrastructure upgrades. Bachelor's degree in Engineering or 10 years of biopharmaceutical experience required. 5+ years pharmaceutical design, CQV, process equipment, utility, PM, calibration, capital project management, cGMP/ GLP environments and regulations experience required. Ability to influence across stakeholders and company functional areas to deliver creative solutions. Knowledge or experience in Biopharma facility technical operations including asset maintenance, calibration programs, and reliability programs. Possess pharmaceutical engineering operational knowledge (Cleanroom design/ operations, process equipment, utilities, facilities, PM, Calibration, validation, & scheduling). A strong practical knowledge of process equipment and the technologies related to large scale cell culture manufacturing or ATMP technology. Experience in directing the design and construction of major office, laboratory and process manufacturing buildings including design, procurement and contracts, including experience in the negotiations and structures of contracts and major agreements. Strong seasoned background in Project Management and understanding in the planning, design, procurement, scheduling, execution and closure of projects. Must possess strong ability to negotiate and influence others internally and externally. Ability to work flexible work schedules. Excellent computer, verbal, and written communication skills. Possess and demonstrate exceptional problem-solving skills. Proven ability to work in a lean organization and creatively tackle problems. Work independently in a matrix environment and manage multiple tasks simultaneously. Experience with health authority regulatory inspections. Strong Global Leader, motivating team player, drives results, excellent communication skills. Capable of managing diverse stakeholders in multicultural environments. Experienced in project management with demonstrated track record to lead through influencing Working safely in person on a predictable and regular in-person basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19. Preferred Qualifications Previous experience in cell and gene therapy To qualify as the head of facilities, the candidate should have prior relevant experience leading a cGMP facilities organization in the biotech or pharma industry To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.Core to our values, we believe there is nothing more important than the health and wellness of you and your family..... click apply for full job details