Primary Objective of the position:
- Responsible of the execution of the Tech Transfer Policies of the department according to the in-force SOP’s.
- Responsible of the execution of the Purchasing and Introduction of new equipment according to the in-force SOP’s.
- Responsible of the execution of the Validation activities in agreement with the in-force SOP’s.
- Prepare and execute the protocols corresponding to the Tech Transfer policies in a Biotech industry, not only from customer to facility but also among departments.
- Evaluate the technical documentation of the potential processes to be transferred (Process and analytics).
- Prepare and execute Cleaning, Process and Analytical Validation Protocols.
- Coordinate the execution of the Validation Campaigns.
- Lead the risk analysis sessions following HAZOP/FMEA methodologies.
- Prepare URS’s of the equipment needed for the execution of a certain project as well as the internal documentation for the right management of the equipment.
- Follow-up the Tech Transfer runs and Scale-Up batches in order to assure the right performance of these batches. Prepare the Tech Transfer report.
- Comply and assure the compliance of the GMP regulations.
- 5 years of experience in tech transfer activities of Biological processes, internal and external tech transfer.
- 2 years of experience in the management of new equipment, from the purchase need to the installation and set-up in the place of work.
- At least 5 years of experience in process validation and cleaning validation activities, desirable in a biotech company.
- Experience in risk analysis and HAZOP/FMEA methodologies.
- Expert in GMP regulations.
- Fluent in English.
- Ability to effectively work within a team and as a leader.
- Immediate incorporation in a young and motivated working environment, in a company in full expansion.
- Attractive remuneration according to experience.
Contact Email: firstname.lastname@example.org