SUMMARY
The Director, Facilities and Engineering Operations is a leadership level role within the California Engineering and Facilities (CFE) team and the Novato Site, responsible for supporting product delivery, BioMarin objectives, and various programs at the Novato manufacturing site, ensuring optimal site performance and cost efficiency.
The incumbent will lead the operation of the engineering, facilities, and maintenance team enabling the Make Assess Release of Drug Substance and Drug Product by ensuring that facilities, utilities, and equipment (FUE) are fit for purpose, aligned with production plan commitments, and compliant with cGMP expectations. She/He will direct the operation of the site utilities, facilities, maintenance, engineering, automation, and validation in support of manufacturing plants, labs, and warehouses.
The Director, Facilities and Engineering Operations will report directly to the head of California Facilities and Engineering and is a member of the CFE Leadership team and an extended member of the Novato Leadership Team (NLT).
RESPONSIBILITIES
Responsibilities include but are not limited to the following:
- Lead a multi-layered organization with strong change management skills and business acumen.
- Responsible for developing department long range plans, annual budgets, and monitoring/controlling budget performance.
- Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management for the immediate team.
- Demonstrated ability to manage both tactically and strategically, to prepare contingency plans and ensure execution of plans.
- Update and Maintain workforce model and adjust & transform the organization with strategic changes to the site.
- Represent Facilities and Engineering at weekly Novato Leadership Tier 4 meeting
- Recruit, direct, coach, and develop a high performing as well as support in creating a highly engaged workforce. Cultivate a culture of safety, quality, and continuous improvement.
- Create a culture that fosters a safe work environment and inclusion.
- Track and trend Novato Site Facility, Utility Engineering (FUE) and Automation as well as Asset Lifecycle Management performance utilizing KPIs and link data to improvement initiatives which will maximize plant uptime in order to meet production plan commitments.
- Maintain Visual Management System to monitor, track and escalate performance in support of the site production plan and initiatives.
- Maintain support for building management systems (BMS) and other plant automation, including the design, implementation, and documentation of system changes. Interface with QA Validation group for GMP systems.
- Assist with troubleshooting complex mechanical or control system problems. Assure integrity of equipment operation as the result of troubleshooting or repair. Periodically review equipment or system alarms to identify adverse trends and potential failure points.
- Perform or coordinate analyses assessing utility capacity and optimization
- Maintain current in technology associated with utility systems, process equipment, control technology, asset lifecycle best practices
- Support site production targets through ongoing support to Manufacturing via Utilities & Facilities Maintenance, Process Engineering, and Automation Engineering teams.
- Support maintenance of engineering documentation for facilities, equipment, utilities and controls in a cGMP compliant state.
- Develop systems for FUE life cycle analysis and planning.
- Lead all aspects of energy and water conservation efforts and identify projects that offer significant financial savings.
- Champion harmonization and alignment within global facility network.
- Champion and sustain an environment of continuous improvement (CI) through active participation in CI projects (Capex or Opex), GEPs and reliability practices, Right First-Time principles, and Lean manufacturing methods.
- Lead change initiatives as needed
- Prepare, implement, and overseeoperating budgets.
- Develop and maintain Novato Facilities and Engineering budget including long range and annual budget.
EDUCATION
- BS or MS in engineering discipline required
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
EXPERIENCE
Required Experience and Abilities:
- Minimum 10 years of experience with the design, installation, startup, and servicing of process equipment, utility systems in the biotech industry.
- At least 8 years GMP/GCP compliant Biopharma operations experience required
- Extensive experience in building management systems (BMS), distributed control systems (DCS), mechanical operation of equipment, and process control and data acquisition systems are essential.
- Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
- Demonstrated ability to partner with other functional group to achieve business objectives
- Experience successfully leading transformational change
- Superior communication skills – oral, written and formal presentation skills with executive management, middle management and line staff
- Creative problem-solving skills. Quickly assesses and resolves issues to minimize downtime. Proactively anticipates and addresses potential issues before they impact production.
- Effectively shifts priorities based on real-time demands and changing production needs
- Makes informed decisions quickly in high-stakes situations
- Maintains order and efficiency while juggling multiple urgent tasks
- Comfortable and effective working indirectly through others
Other:
- 3- 4 days/week on-site presence required.5 days/week site presence may be necessary depending on levels activities
- Availability during weekend and night may be necessary for unplanned emergencies
- Ability to travel 5-10% desired
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Director, Facilities and Engineering Operations
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The salary range for this position is: $176,700 to $242,990. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.