Lead Process Engineer – Tech Transfer
Purpose
This Technical Engineering role will play a key part in the development in the drug product facility. This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction. This includes but is not limited to: Tech Transfer, Validation programs & strategies, technical support and process improvement projects, network support & collaboration
Responsibilities
Compliance
•Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
•Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
Process Engineering & Validation
•To lead and execute process engineering and validation activities to support the technical transfers
Projects
•To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross functional teams to establish scope in improvement projects up to a fully commercial site.
Continuous Improvement
•To manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team. Use scientific, product
and process understanding as a basis for developing
risk-based approaches to investigations and trouble shooting.
•Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
Technical Expertise
•Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
•Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects.
Qualifications
•A bachelor’s Degree or higher preferred; ideally in Science, Engineering or other Technical discipline.
•Minimum 4 years’ experience ideally in manufacturing, preferably GMP setting
•Green Belt preferable
•Process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
•Proven track-record in delivering results in a world-class supply organisation.
•A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
•Innovative thinker, with excellent decision-making and problem-solving skills.
•Experience of working in a cross functional environment.
•Knowledge of and experience in applying Six Sigma and Lean methodologies.
•Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
•In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
•Experience of executing and/or managing through equipment and process validation in a sterile environment
•Good shipping/Filter/Cleaning validation knowledge required
•Knowledge of QbD/CPV desirable
•Excellent report, standards, policy writing skills required
•Automation and MES knowledge
•Experience in audit preparation and execution desired
•Having a strong safety ethos
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