Senior Packaging Expert

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community. In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do. Because at Norgine, we transform lives with innovative healthcare solutions.

This is a 12-month Fixed Term contract position. The person holding this position will report to our Associate Technical Director.

Purpose of role: Provision of technical packaging support for new and existing products across Norgine sites, Contract Manufacturing Organisations (CMO) and partners. Accountable for ensuring that all packaging components are developed to meet regulatory requirements and conform to required specifications and standards.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

• Design, develop and implement pack designs (technical drawing) for new packs and changes to existing packs.
• Accountable for working with engineering/process personnel to understand equipment requirements and limitations that need to be considered.
• Act as technical lead for implementation of new packaging, changes to existing packaging (e.g. material or component suppliers), line extensions, technical transfers, CI initiatives and resolution of packaging issues.
• Including leading/arranging packaging trials, project management, development of project plans and management of risks and budgets, as required.
• Input and maintain the variable data and recipes required for Serialisation.
• Provide expertise and leadership regarding GS1, GTIN & NTIN standards as applicable in packaging in relation to variable data and recipes.
• Ensure standard technical drawings are maintained.
• Review and upload of technical drawings and artwork onto relevant systems e.g. RIM Veeva.
• Create new technical drawings when required for any new or changed packaging components.
• Lead packaging related activities linked to; Quality events, Customer Complaints, IMC actions, Change controls and CAPAs.
• Define, co-ordinate and execute associated CAPAs.
• Support of Change Controls with a potential impact on product quality within their assigned portfolio.
• Leading change controls for packaging changes and completion of packaging related MSAT functional impact assessments.
• Responsible for leading multiple projects across internal manufacturing sites and with external partners (CDMOs/CROs) to support packaging activities, as required.
• Responsible for the execution of the packaging component and packaging process elements of the Product Lifecycle Management (PLM) activities for assigned portfolio of products, including risk assessment, risk management and knowledge retention.
• Author and review appropriate sections of regulatory dossiers/supporting information for post approval changes and associated activities.
• Establish and maintain technical compliance for all designated packaging components in accordance with standards (e.g. GS1), GxP and company policies and procedures.

RELATIONSHIPS: Work cross functionally as a project lead or team member on approved projects with representatives from global and local departments, CMOs and partners. Formal reporting of project status to Management and Project Sponsors.

Skills & Knowledge Required:

• Degree in a scientific or engineering discipline.
• Previous experience of the pharmaceutical industry with experience of working within the industry and experience of matrix management.
• Ability to lead cross functional projects to deliver against key project milestones and deadlines.
• Inquisitive mindset with the drive to make improvements.
• Understanding of the Regulatory compliance requirements within Europe, Japan and the USA.
• Experience of supporting regulatory submissions and technical protocol/report writing.
• Comprehensive knowledge of primary and secondary packaging suppliers.
• Good understanding of packaging production processes, lead times and costs.
• Experience in the application of new and existing pharmaceutical packaging processes.
• Experience of working with and development of multiple types of packaging for different pharmaceutical dosage forms.
• Knowledge of the technical requirements of pharmaceutical artworks.
• Understanding and implementation of lean six sigma.
• Experience in leading root cause analysis investigations.
• Coaching and mentoring of team members.

Desirable:

• Packaging qualification from a recognised professional body, for example Institute of Packaging Qualified (Diploma).
• Working knowledge of ICH Q8, Q9, Q10 and Q12 guidelines and Medical Device Regulations (MDR).
• Working knowledge of sustainable packaging practices.
• Fluent in French in addition to English.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you'll have with Norgine, then apply here.