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Packaging Engineer - Serialization

Location Cork, Ireland

Packaging Engineer - Serialization

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. 

Duties

Note, this role will be primarily focus on Serialisation activities initially. When the programme nears full implementation, this role will switch to focus more on packaging engineering activities, working with internal groups and CMOs to ensure successful on-time packaging introduction. This will include new packaging components qualification, artwork approval, overseeing packaging related IQ, OQ and PQ, and ensuring compliance with specifications and regulatory guidelines. This role will also involve the project management of key initiatives such as technical transfers and process improvements.

  • Packaging Engineering Duties
  • S/he will collaborate with internal groups and CMOs to ensure successful on-time packaging introduction, which includes package testing, artwork approval, overseeing machinery IQ, OQ, and PQ, and ensuring compliance with specifications and regulatory guidelines.
  • Develops strategies to implement changes to processes.
  • Provide Packaging Engineering support for the development and launch of new products. 
  • Lead on-site implementation of changes and packaging-related launch activities at CMOs.
  • Team member for technical packaging projects on cross-functional project teams.
  • Evaluate new packaging process or packaging to increase productivity, meet packaging objectives, and/or reduce costs without sacrificing quality.
  • Design, test, and implement secondary, tertiary, and selected primary packaging components. Write technical reports to support the component selection process. Perform financial analysis to support new or revised packaging proposals.
  • Author SOPs, work procedures, packaging specifications, package design testing protocols, and oversee testing of the packaging components and packaging systems.
  • Identify new packaging suppliers as needed. Justify, arrange qualification, and participate in audit as required. Work with and travel to contract sites to jointly develop package systems, batch records, distribution and handling methods, and any activities involved in properly transporting the drug throughout the supply chain.
  • Approve artwork from a technical perspective
  • Author technical documentation including all specifications, work procedures, and package design testing protocols for approval of packaging designs.
  • Will be a member of multidisciplinary project teams and be called on to lead teams for tasks that are focused on packaging issues.
  • Present packaging project statuses at project and department meetings.
  • Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification and approval.
  • Evaluate and implement new technologies to enhance productivity, safety, and meet requirements.
  • Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
  • Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
  • May take primary role in technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.
  • Prepares documents for Regulatory Filings
  • Other duties as assigned.

  • Serialization Duties
  • Serialization SME for BioMarin’s Global Serialization Programme – this covers a broad range of competencies including but not limited to GS1 standards; artwork coding requirements; regulatory requirements; distribution & warehousing best practises; L4 EPCIS messaging
    • Maintain a deep knowledge of all ongoing serialization regulatory requirements and implementations at the various sites and distribution partners ensuring successful implementation and mitigating risks as necessary
    • Serialisation Master Data owner – work with other relevant functions to ensure there are efficient processes in place to support the introduction of new SKUs into the future
    • Execute change controls and master data updates as required
    • Build Serialisation knowledge and act as SME for all related queries. Build Serialisation capabilities amongst the broader organisation. Develop FAQ and best practice documents to support this.
    • Lead the cross functional troubleshooting of any Serialisation related issues or alerts throughout the supply chain and ensure systemic fixes are put in place to prevent re-occurrence.
  • Project manage a variety of Serialisation Implementation projects, from CMO pack site validation activities, to 3PL and Wholesaler Readiness, and L4 Technical Integration activities.  
    • Provide regular updates at Governance meetings
    • Where areas of risk are identified, support the risk assessment process and act appropriately with the teams to mitigate or remove the risk.
    • Act as the key link between the Global Packaging Engineering Group and CMO Operations groups to deliver commercial packaging processes or process updates.
    • Develop Serialization training plan to ensure Serialization knowledge and activities are embedded cross functionally across the broader business

  • Skills
  • Minimum 2 years as a Packaging Engineer in the Biotech/Pharmaceutical industry with increasing responsibility. Independent thinker with demonstrated skills working in teams or leading project teams
  • Ability to multi-task and manage timelines
  • Prior project management experience or qualifications would be favourable
  • Serialisation and GS1 experience would be preferred
  • General Supply Chain experience from Packaging through to Distribution & Warehousing would be preferred.
  • Must be a team player and be skilled at influencing without authority.
  • Experience working with and knowledge of ISO and ASTM packaging test protocols.
  • Experience working with packaging artwork is a plus.
  • Working knowledge of packaging manufacturing processes
  • Proficient in MS Office: Word, Excel, Outlook, PowerPoint, CAPE or TOPS
  • Proficient in MS Project.
  • Excellent organizational, interpersonal communication, and problem-solving skills.
  • Ability to find, communicate, and implement ways to continuously improve processes.
  • Proficiency with Oracle or other materials management systems and Trackwise is desired.
  • Experience with CAPA, FMEA, RCA tools.
  • Highly developed organizational and project management and influencing skills.
  • Process development or technology transfer experience preferred.
  • Excellent written, verbal, and presentation communication skills.
  • Demonstrated strong analytical skills and judgment.
  • Effective decision making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
  • Demonstrated initiative; results oriented, initiative to institute change.
  • Recommend systems to improve department policies and practices.Adobe, AutoCad or ArtiosCad are a plus. Experience packaging combination products is a plus.
  • Proficiency with Oracle or other materials management systems and Trackwise is desired.

    Education
    Degree in Engineering, Science or Business Discipline is required.

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

 This role can be based in either Shanbally or Dublin.

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.


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

About our location

Cork

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