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Process Validation Associate

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

This position reports to the Process Validation Manager and is responsible for multi-modality process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation. Process validation activities may include drug substance manufacturing processes, drug product filling processes and completion of validation risk/impact assessments and evaluations, etc.

Job Responsibility:

  • Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
  • Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements
  • Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures
  • May participate on sub-teams
  • Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
  • Participate in multi-departmental meetings & project teams
  • Identifies and assists with implementation of improvements to Process Validation systems (department level impact)
  • Generation of process validation master plans, core validation master plans and additional supporting documentation
  • Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories
  • Coordination of process validation activities involving cross-functional, multi-departmental teams including Manufacturing , Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and others

Requirements:

  • Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
  • 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
  • Organizational and management skills to participate in multi-discipline project groups
  • Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate
  • Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations
  • Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations
  • Proficiency with technical writing expected
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point

Nice to have:

  • Training in project management is preferred
  • Experience and proficiency with other applications is highly beneficial
  • The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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