Description

Who We Are

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.

• Implement, and manage capital projects using industry best practices and BioMarin business processes.

• Manage the scope, deliverables, schedule, project team, and budget for capital expenditure (CapEx) projects.
• Participate in the development and evaluation of RFP and bidder/vendor analysis for General contracting and engineering services when design build method used
• Works directly with project controls to prepare and update project status, schedule, resource, and cost reports within Oracle based tools (OPPM & P6) for the use of numerous BMRN departments
• Identify Develop and oversee internal and external project team(s) composed of various BMRN engineers, EHS&S, IT, manufacturing, maintenance, and etc. personnel.
• Ensure internal employees, consultants & contractors working on any construction related projects maintain compliance with all GMP requirements (including training), EHS&S and security requirements, including completion and review of Job Hazard Assessments and BioMarin policies.
• Evaluate, prepare, & submit OPPM project intake forms once a pre-governance screening has taken place and project will move forward.
• Manage all governance requirements utilizing the project lifecycle business process and Capital Portfolio Management Guidelines.
• Works with project controls for the generation of project cost accrual information, in service dates, financial long-range planning, & other financial and planning exercises.
• Coordinate/support engineering and automation design, commissioning, qualification and the QA Validation groups as appropriate.
• Proactively look for and recommend improvements in site processes and procedures.
• Represent the Capital Project Delivery group with good communication and presentation skills.
• Provide monthly reporting on Projects to Senior Management as required.

• Minimum 10 years of project management experience preferably in the biotech or pharmaceutical organization
• PMP certificate highly desirable.

• Ability to work with minimal direct supervision: meet deadlines, prioritize assignments, provide recommendations and effectively communicate updates.
• Experienced with communicating with in supporting Executive Management as well as providing direction support for multiple projects simultaneously.
• Must be very organized and possess strong verbal and written communications skills
• Must be proficient with Internet navigation, Microsoft Office (Outlook, Word, PowerPoint, Excel, Project, Teams, Sharepoint), Adobe Acrobat
• Familiarity with Oracle Primavera P6
• Should be flexible to working outside the core business hours (occasionally on short notice, and a limited basis) as needed.
• Proven ability to manage multiple and fast-moving priorities.

• Ability to work well in a fast-paced collaborative team environment within a rapidly evolving business environment.
• Skilled at solving multi-dimensional problems with both quantitative and qualitative variables.
• Ability to lead and influence others in support of company objectives.
• Excellent decision making and cross functional team building skills.
• Solid understanding of GMP, GLP, and non-GMP project requirements
• Able to read and understand architectural and engineering plans and specifications.
• Good understand of construction contract types, delivery methods, and construction management processes.

• BS degree from an accredited university in a construction or engineering related field.
• Could be a combination of AS degree and industry experience.

• Project controls
• Project Engineering both Automation and FUE
• Site Engineering and Automation
• Commissioning and Qualification
• Site Validation
• Quality Validation
• All User groups in business (TOPS, R&D, Corporate)