The Principal Engineer will lead cross functional teams and will deliver projects in the key focus area for Technical Operations. The Principal Engineer will provide technical support and leadership to top line growth, enhance reliability, compliance & efficiency of product value chains end-to-end (i.e. support life cycle management from API to Drug Product, integration of Pharmaceutical Development and Manufacturing Operations, in partnership with VCM-Value Chain Management and PCM-Planning & Customer Management).
Product Technical Leadership and Support Responsibilities
Ensure fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place;
Plan and execution of drug product manufacturing site activities from transfer through commercial launch;
Coordinate and execute the product introduction at commercial sites covering raw materials, formula, process, packaging and device integration into the finished drug product.
Technology Transfer Projects
Lead the drug product Technology Transfer projects and investigations in support of marketed products pre and post launch (Technical Life Cycle Management);
Lead and support process Capability/Quality Improvement efforts and breakthrough improvements in Cost of Goods Sold (COGs);
Support internal & external manufacturing sites to define improvement goals and plans (benchmark driven) and oversee implementation providing leadership and advanced expertise;
Prepare quotations for upcoming projects in terms of resources and timelines and taking into consideration the customer’s as well as regulatory requirements;
Manage internal and external communication, ensuring alignment with the various local and global functions assigned to the management and/or execution of manufacturing Technology Transfer project.
Technology Strategy: Innovation & Standardization
Develop, manage and transfer advanced knowledge on new process technologies and equipment, with main focus on Liquids &Creams (including sterile eye drops), Process Analytical Technology and also Continuous Manufacturing;
Working closely with the Advanced Technologies Center of Excellence, support the selection, testing and deployment of technologies with a contribute in developing Platform Standards on process technologies, equipment and best practices to internal and external manufacturing sites;
Scout of the market for technologies & innovative approaches and implementations leading.
Lead multifunctional projects in support of new technologies and initiatives, coordinating with an including all relevant areas and external partners
Drug Product Technical Ownership
Own globally drug product technical responsibilities (DPTO function) of one or more assigned products;
Provide technical support for investigations during commercial production as well as driving investigations that occur during validation projects;
Provide technical expertise related to the manufacturing of assigned products and deliver stakeholders and sponsors update, according to existing communication product life cycle model.
Participate in the CPV (continued process verification) program by reviewing plans, protocols and reports.
Review / approve annual product reviews (APR)
Skills and Competences required:
Degree in Pharmaceutical Chemistry and Technology, Chemical Engineering or Chemistry, Engineering in a industry related field (Mechanics, Electronics,…). A Phd in one of these disciplines will be considered as an asset;
A previous experience of 8-10 years in a similar role
Strong Project Management skills, experience and qualifications; FPX certification preferred
Experience with solids and liquids processing requirements/techniques, processes, material sciences and technology transfer;
Experience with sterile parenteral preparation is an advantage;
Understanding of the pharmaceutical business and industry knowledge;
Experience and knowledge of Continuous Manufacturing Equipment for Oral Solid Dosages
Systems Qualification and/or Process Validation Experience;
Experience in Manufacturing cGMPs, Operational Excellence, Lean, Process and Design Excellence;
Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S;
Ability to design and lead technical teams in support of Root Causes Analysis on processing deviations and Supply Chain escalations and coordinate action planning and execution;
Ability to independently develop and assess Business Cases, perform feasibility studies, develop action plans related to Network, Assets Optimization, Processes Improvements, Costs and Quality improvements.
Knowledge of Kepner-Tregoe Problem Solving methodology
Fluent in written and spoken English
Statistical Skills will be considered as an asset
. Personal and interpersonal skills / Leadership skills
Ability to lead cross functional team – for those engineers / scientist leading projects in the site
Ability to manage complexity and change
Ability to interact at different levels of the organization
Ability to work under pressure, handle conflicting interests
Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
Ability to create a result oriented (project) team – for those engineers / scientist leading projects in the site
Costumer and business focus
Problem solving skills and attitude
Personal attitude and mindset
Drives for innovation and change to ensure competitiveness
Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
Willing to place the goals of the team first and work with others towards these goals
Communicative / Motivator / Negotiator having impact
Showing a high sense of responsibility regarding professional activities