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QA Packaging Technical Lead

Location Cork, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients’ lives.

QA Packaging Technical Lead - Shanbally, Ringaskiddy, Cork

This position within the QA department provides oversight of projects being completed in the Packaging Department, including process improvements, new equipment, new process and new product introduction. Provide technical support to the QA Packaging group to continue to meet commercial release requirements.

General QA Packaging Technical Lead Responsibilities:

  • Coordinate effective planning and execution of projects related to the packaging department.
  • Provide Quality oversight of change controls related to packaging department projects.
  • Provide Technical expertise to Packaging Department, Quality Assurance and external teams
  • Assist in trouble shooting and optimization of processes.
  • Ensure consistent delivery to stakeholders and effective communications
  • Coach and develop individuals within the team
  • Collaboration with Validation, Package Development, and Packaging Department to ensure timelines are managed effectively
  • Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
  • Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
  • Lead and implement initiatives that add value to the Quality Assurance and site operations
  • Deliver on capital/budget
  • Scope out future efficiencies/ optimization opportunities
  • Other duties as assigned.

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

REQUIRED:

  • Degree or 3rd level qualification (Science, Quality).
  • Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
  • Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Proficiency in PC skills such as Excel, Word, PowerPoint.
  • Proven decision-making capability with full accountability and responsibility.
  • Demonstrated coaching skills.
  • Excellent written and verbal communication skills.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.

DESIRED:

  • Experience as QA contact supporting large scale projects in a manufacturing or packaging operations setting
  • Experience in lot release of device and combination packaged products.
  • Evidence of Continuous Professional Development.
  • Evidence of Validation knowledge/experience.
  • MES experience.
  • Good knowledge of Lean / Continuous Improvement practices and root cause analysis.

BEHAVIOURS:

  • Always focused on the patient and customer needs.
  • Resilient profile with the ability to deliver in a challenging environment.
  • Ability to engage and manage multiple stakeholders to achieve the objective.
  • Curious with learning agility.
  • Operationally excellent, with attention to detail.
  • Organised with systematic approach to prioritisation.
  • Process orientated to achieve the business objective


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Cork

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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