Manufacturing Bioprocess Specialist

Overview
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.
Manufacturing Bioprocess Specialist (MPI)
Onsite Role - Shanbally, Ringaskiddy, Cork
Closing Date: 10th November 2025
Summary Description
We are a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organisational skills.
Responsibilities
Reporting to the Manufacturing Manager, the primary role of the MPI BPS is to support Manufacturing areas in successful site start up, process validation and product launch activities, and to lead and implement initiatives that add value to operations.
The MPI BPS will work in a team environment that is aligned with the Manufacturing value stream, and will be committed to continuous improvement, process understanding, personal development, and demonstration of Manufacturing techniques that will result in compliant manufacture of Drug Substance, Drug Product and Packaged material.
Leading cross functional teams in development & implementation of Operational readiness plans across the portfolio of manufacturing projects (CAPEX, OPEX, Continuous Improvement, etc.).
Troubleshoot and resolve technical issues using various lean & six sigma tools.
Develop and define the scope of technical solutions, coordinating people and processes under site change control systems to ensure timely project delivery and desired results.
Coordinate internal resources and third parties/vendors to ensure project execution meets safety standards.
Accountable for creating and presenting business cases for Manufacturing projects to secure stakeholder approval and ensure alignment with organisational goals
Responsible for conducting risk management across the project lifecycle and implementing mitigation plans to minimise risks
Support and partner closely with peers to ensure Manufacturing systems and practices are consistent throughout the organisation
Own, investigate, write, and approve associated deviations as well as support & coaching Biotechnicians in these functions – ensure adoption of 'zero late' mentality in meeting timelines
Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution
Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviors.
Deliver programs at site/functional level realising business improvements while engaging with employees
Support operational strategic plans while building Lean / Six Sigma knowledge amongst peers
Implementing changes and process improvements to ensure elimination / significant reduction in frequency of similar deviations occurring
Build the capability to continuously improve the site's performance in Quality, Safety, Service, Cost and Innovation towards the goal of Zero accidents, Zero defects and Zero waste
Lead site projects and programmes aimed at improving the Continuous Improvement culture and delivering business benefit.
Scope
Manufacturing Bioprocess Specialist has scope to initiate process, cost and continuous improvement ideas.
Education
Bachelor's degree in a Science or Engineering related field or equivalent experience is preferred.
Certification in one or more of the following disciplines: 6 Sigma, Green Belt, Black Belt, Lean, Change Management is desirable.
Qualifications in Project Management is desirable.
Experience
Demonstrable experience Root Cause Analysis tools and Change Control systems.
In depth understanding of Process Engineering and technologies pertinent to Drug Substance, Drug Product and Packaging is desirable.
Strong training, coaching and mentoring skills.
Knowledge of the DeltaV process control platform is desirable.
Knowledge of the Manufacturing Execution Systems (MES) is desirable.
Knowledge of FDA and EU regulations is desirable.
Contacts
Work closely with Process Development, Manufacturing Science Group, Quality Operations, Facility Services and Manufacturing personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
Work closely with relevant external partners to ensure project success.
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.
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