Sr. Engineer, Novato Engineering & Facility Services
Location Novato, California
Sr. Engineer Novato Engineering & Facility Services (NEFS)
Department / CostCenter:
Reports to (Job Title):
Manger, Engineering NEFS
Novato South Campus
October 10, 2019
State the overall function or purpose of the job.
NEFS Engineering provides critical technical support, guidance and strategic vision to ensure that theprocess/facilities/utilities/equipmentfor BioMarin's domestic clinical/commercial manufacturing buildings and warehouses are designed, operated and maintained in a manner consistent with GXP and best practice asset lifecycle management.
The purpose of this role is to provide engineering support for process, facilities and utilities at BioMarinNovato locations; the initial primary focus of this individual will be on processing equipment as a dedicated Engineer to the Galli Upstream operations. This is an individual contributor position as part of a site-based Engineering team.
The engineer will be responsible for ongoing support to Novato manufacturing and support to ensure process equipment performs its intended function when required. This role will support the design, engineering, commissioning and qualification of new or modified utility equipment systems and/or GMP manufacturing process equipment and warehousing facilities. Focus will be on modification to existing FUE systems and smaller capital projects and supporting the global engineering team in delivery and receipt and turnover of FUE equipment on large capital projects. In addition to system modifications, the engineer will be responsible for troubleshooting investigations as well as monitoring systems as SME and making recommendations on improvements.
List the major responsibilities of the job.
- Demonstrate an in-depth technical knowledge of FUEsystems to support the manufacturing, and warehousing of pharmaceutical and biological products
- Act as engineering resource on cross-functional project teams
- Apply extensive practical expertise in their area(s) of knowledge
- Advance safety, health and environmental stewardship at BioMarin through technical decisions, guidance and leadership
- Effectively manage internal and external relationships with customers, key stakeholders and vendors
- Develop and maintain effective communication with peers, subordinates and senior management
- Demonstrate the ability to be self-directed with limited guidance and oversight from management
- Support development of internal engineering practices and procedures
- Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance
- Demonstrate leadership, effective collaboration, partnering and teamwork skills when interacting with internal and external resources
- Actively participate in technical, tactical and strategic reviews/discussions
- Remain current on all training requirements
- Demonstrate the ability to plan and implement small projects
- Identify and champion projects that will successfully support BioMarin business goals and objectives
Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This role is critical in the support of Novato Make, Assess, Release GMP operations.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
- BS or MS in Chemical, Mechanical, or otherEngineering degree from an accredited university. Relevant job and years of experience may be substituted in place of a degree.
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
- A minimum of 3 years’ experience in processes, facilities clean utilities and/or plant utilities, preferably in the biotechnology or pharmaceutical industry.
- Experience with executing commissioning and qualification activities.
- Strong organization, interpersonal, oral and written communication skills.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
- While primarily a day shift job, hours will vary based on the needs of the position. This position may require occasional overtime and weekend/holiday work depending upon various facility requirements.
- Provide after-hours leadership/managerial on-call support as required.
- While performing the duties of this job the employee is frequently required to stand, walk, sit, talk or hear, reach with hands and arms, climb stairs or ladders, balance, stoop, kneel or crouch.
- Specific vision abilities required by this job include close vision, depth perception, color vision, peripheral vision, and ability to adjust focus.
- While performing the duties of this job, the employee occasionally work near hazardous chemicals, or radioactive or biohazardous waste.
- The noise level in the work environment is usually moderate.
- The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Describe any equipment required to perform the job.
- Typical office hardware and software, which includes the basic suite of Microsoft business applications
List the key positions, internal and external, with which the job incumbent must interact.
- This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.
- The Engineer -FUE will work closely with other support groups such as Engineering, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Global Engineering, EHS&S, Quality Assurance and Quality Control to ensure that BioMarin assets are well managed throughout their lifecycle.
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
- Lead other Engineers from the team as required. Engineers can be assigned to work with the Engineer to support relevant activities in their area.
- Lead external consultants to complete critical activities and deliver compliant work on time and to budget.
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
- Act as a champion and change agent in support of the Engineering Department and other BioMarin continuous improvement efforts
- Provide insightful and strategic input during Long Range Planning efforts
- Demonstrate the ability to effective work in both tactical and strategic environments
- Be perceived as a strong candidate when a mentoring or coaching opportunity arises
- Demonstrate the ability to engage, motivate and positively influence others’ in the pursuit of achieving BioMarin goals and objectives
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