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.

• Lead a team of automation and MES engineers in the support of site operations across a wide variety of technology platforms.
• Overall responsibility for both the MES and Automation Systems (e.g. PLC, DeltaV, Pi, OEE and BAS) required to support Drug Substance & Drug Product Manufacturing throughout the entire lifecycle.
• Preparation and management of operating budgets to support site operations.
• Representation at change control reviews and site quality review teams.
• Key contributor to the site’s business continuity planning efforts.
• Definition and management of the automation and MES philosophy for the site.
• Defining automation and MES strategies for future projects.
• Ensuring the site Automation and MES systems are maintained in a GXP state.
• Maintain a safe working environment by continuously promoting safety awareness, recognising and rectifying unsafe conditions and performing thorough investigations when accidents occur.
• Overseeing the delivery of Automation & MES Projects at Shanbally
• Ensuring the system is supported through its entire lifecycle.
• Ensuring process metrics for the function are developed, reviewed and updated, that measure effectiveness towards achieving goals, provide visibility to improvement opportunities, and track progress of improvement initiatives.
• Instil the use of Right First time (six-sigma) and lean practices leading to operational excellence.
• Developing and demonstrating a pro-active approach to safety, environment and regulatory compliance. 

• Participate in the change control program for modifications to qualified systems
• Use knowledge and expertise to challenge / question and coach / mentor others to do the same.
• Consider global/site implications for decisions made and actions taken.
• Uses cost-benefit thinking to set priorities.
• Analyses tasks to identify efficiencies and ensure efforts are focused on business critical and business improvement activities.
• Other duties as assigned.

• Experience with Automation and Manufacturing Systems including use and support requirements
• Experience with system implementation and SDLC requirements
• Experience with the data interdependencies of integrated systems
• Minimum 8 + years’ experience in a Bio-Pharmaceutical or equivalent type life science industry
• Knowledge of both project and GxP change control procedures incl. experience with change impact assessments
• Demonstrated strengths with trouble-shooting and resolution of technical issues and challenges
• Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
• Must possess a thorough understanding of current industry guidance, including GAMP 5
• Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
• Experience/Knowledge in one or more Manufacturing support systems: ERP, LIMS, EDMS, QMS, MES
• Experience/Knowledge in multiple Automation Platforms, DCS, PLC etc
• Proficiency with MS Office applications (Word, Excel, Visio, Project, Power Point).
• Good verbal and written communication skills
• Good organizational skills
• Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination

• 3^rd Level qualification in Engineering, Business Information Systems, Physics & Instrumentation or Equivalent
• Experience with Manufacturing Execution systems, preferably Werum PAS|X
• Experience with Automation systems, preferably DeltaV, Siemens PLCs, OSI PI
• Experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects
• Experience in Lean Six Sigma methodology (preferably Yellow/Green Belt in Lean Six Sigma)

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.