Priniciple Packaging Engineer - Dublin - 11 Month Contract
The Principal Engineer provides leadership, direction and advanced technical expertise to the Global Packaging Engineering & Technology organization in their respective area or areas of specialization (i.e., Packaging Technology, Package Design, Packaging Engineering, Serialization, Product Security, Packaging Process Development & Optimization, etc.).
This role is also involved in the development, launch and life cycle management of primary and/or, secondary and/or, tertiary packaging components and/or equipment maintenance and engineering projects.
o New Technology Acquisition
o Packaging Equipment
o New Package Introduction
o Combination Product and Device Packaging
o Packaging & Art-Work Specifications
o Packaging Process Development and Optimization
o Identification and qualification of alternate sources for packaging components
· Responsibility for Process Ownership requires the incumbent to ensure a clear definition of the process start to finish is understood; quality documentation of the process is maintained (i.e., work process map, process summary, training materials, SOPs, etc.); establish process goals and targets; monitor process performance; guide, influence and train others to ensure the process is followed consistently, and seeks to continuously improve the process.
· Will develop and maintain the technology capability strategy (for their specific area or areas of expertise), which defines the capability we need to deliver our services and the actions we need to take to maintain and continuously improve that capability.
· Lead, manage and execute all aspects of a project. Accountable for delivering on specific performance indicators, including but not limited to:
o Documentation cycle time (Packaging Component Specifications, Bill of Materials, Technical Protocols and Reports, Validation Master Plan, Regulatory Filing Support Documentations, etc),
o First time right documents,
o Cost of goods productivity improvement
o 100 % filing submissions on time and correct,
o 100 % Regulatory responses on time and correct, etc
· Will work with external contract packaging network and internal packaging sites to create or enhance packaging capabilities to deliver the needed capacity, quality and quantity of packaged goods required by our patients. Will partner with sites to ensure quality in product packaging and drive elimination of customer complaints relating to packaging.
· Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
· Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
· Promote continuous improvement in efficiency, quality, and safety through technical development, education and training.
· Lead and conduct complex technical investigations
· Author, review, approve regulatory and technical documentation, including but not limited to CMC, SOPs, Validation Master Plans and Technical Reports.
· Provide technical perspective during internal and external audits, regulatory inspections and due diligence.
· Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
Interface directly with all Customers and ensure highest level of Customer satisfaction
· To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
· Represents Global Packaging Engineering & Technology on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions
Serve as a Package Engineer to the Product Technical Teams or Site Support where necessary in ensuring continuous safe supply of commercialized product (25%)
Key skills required
Deep expertise in several technologies applicable to the functional area. Possesses technical knowledge and experience in problem-solving methodology. Understands the application of process knowledge and controls to the applicable functional area. Able to serve as effective project team member and/or leader and is able to assist in business case development. Strong verbal and written technical communication skills. Knowledge of the relevant cGMP, ICH and global Regulatory CMC guidance documents applicable to the function. Able to serve as packaging SME in CMC submissions technical content relating to packaging. Experienced in technology transfer practices. Previous knowledge of CMC development practices. Functional commercial manufacturing experience and CMO/CRO experience. Previous experience as a regulatory inspection technical SME. Continuous improvement project experience and capable of applying multiple methodologies. Able to teach the use of problem-solving methodologies. Able to inspire cross-functional teams. Hands-on experience and exposure to technologies applicable to the functional area. Proven capability of acquiring knowledge and applying problem-solving methodologies. Proven capability of performing process capability and statistical process control calculations.