Technical Transfer Engineering Lead

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team as a Technical Transfer Engineering Lead at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities. Working with advanced technologies and diverse teams, you'll help maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.

The Technical Transfer Engineering Lead is responsible for planning and managing engineering projects related to products transfer. Specifically, this role involves coordinating, monitoring, and planning the project as well as forecasting its costs and predicting the timelines and deadlines that characterize the individual development phases.
The Technical Transfer Engineering Lead has both managerial and engineering responsibilities, drafting executive work plans, defining the budget, managing technical aspects, and coordinating the project team, in particular for sterile departments/packaging.
Finally, the Technical Transfer Engineering Lead contributes to identifying new business opportunities by defining the CAPEX of activities necessary for the engineering of new technical transfer processes.

The Technical Transfer Engineering Lead doesn't manage own team but a multidisciplinary project team and he/she reports directly to TT Engineering Supervisor. 

SPECIFIC TASKS/PRIMARY ACTIVITIES:

The specific tasks of the Engineering Lead include:

• Quotations for new clients. In identifying new clients and new business opportunities, the TT EL collaborates with the Business and Technology Transfer functions in formulating the economic proposal. Specifically, it is the responsibility of the TT EL to define the CAPEX related to the engineering of the new process, especially for sterile departments/packaging.
• Project planning. The TT EL is responsible for identifying the best strategy to implement the project and drafting a detailed work plan of the development phases that compose it (GANTT).
• Internal communication. The TT EL must provide timely updates on the progress of the project to their Manager through specific reporting.
• External communication. The TT EL may interact with suppliers, contractors, external entities, or other external figures that may be useful for the completion of the project.
• Budget management. The EL is responsible for managing the project costs. This includes: cost evaluation, CAPEX approval (Capital Expenditure) through the drafting of a CAR (Capital Appropriation Request), monitoring, and controlling expenses.
• Project team management. The TT EL must coordinate, organize, and monitor the activities of the work group.
• Drafting of URS (User Requirements Specification). The TT EL is responsible for drafting the technical reference document that must be prepared for the purchase of equipment and machinery.
• Execution of FAT (Factory Acceptance Test)/SAT (Site Acceptance Test)/Commissioning.
  The TT EL is responsible for coordinating, organizing, and monitoring the functional tests to validate the design hypotheses listed in the URS.

REQUIREMENTS:

• Bachelor's Degree required, preferred Fields of Study: Chemical/Mechanical Engineering, Biomedical Engineering or related scientific field
• 2–5 years of experience in pharmaceutical manufacturing, engineering within a GMP-regulated environment, preferably sterile and packaging.
• Experience in sterile pharmaceutical manufacturing/packaging
• Strong knowledge of GMP, validation principles including IQ/OQ/PQ protocols and FDA/EMA regulatory requirements
• Experience with Sterile environmental, equipment design, revamping of existing ones
• Expertise in Microsoft Office suite
• Excellent written and verbal communication skills in English
• Ability to work independently and as part of cross-functional teams
• Strong problem-solving abilities and analytical mindset
• Experience with risk assessment methodologies
• Knowledge of data integrity requirements and 21 CFR Part 11 compliance
• Ability to manage multiple priorities effectively
• Travel between sites may be required
• Flexible schedule may be necessary for time-sensitive validation activities