Overview
Execution of activities in Purification production department (Downstream), following operating
procedures and GMP requisites.
Under supervision of Purification Supervisor and area technicians, performance of those
specific-department activities; equipment preparation and execution of standard producing
procedures under cGMPs regulations, as a part of the work team.
Production operations associated to their department will include, among others,
chromatographic resin and column handling, as well as direct and tangential filtration systems,
intermediate product handling, excipients and solutions preparation, and equipment and
material preparation.
Responsibilities
Execute Protein Purification activities in accordance with specifications from Research
and Development department and quality standards of Company.
Write Standard Operating Procedures (SOPs) corresponding to equipment and tasks
of their department.
Write Batch Records documents.
Production equipment preparation prior to use as well as after use (cleaning,
sanitization, etc.).
Register all production activities in logbooks, batch records (BRs) or documentation
according to guidelines and quality procedures of company.
Preparation of media, buffers and process solutions, as well as filtration and/or
sterilization.
Support tasks of production material preparation, conditioning and sterilization.
Participate in production equipment installation and qualification as well as provide
support on its maintenance, calibration and requalification.
Participate and propose improvements in production processes, records and Company
activities, fostering continuous improvement within section.
Follow production programs as well as formation and training.
Provide information and support in research of quality deviations, as well as participate
in implementation of follow-up plans for corrective and preventive actions associated to
each deviation.
Interact with Suppliers of routine-use equipment and items in production activities.
Interact with the other company departments, always fostering friendly work
environment.
Modification and updates of Batch Records documents due to deviations,
improvements or other reasons.
Keep a respectful activity towards Environment complying with current Company
regulations and requisites of safety, hygiene and environment.
Participate in the work teams assigned to each customer, attending to meetings,
teleconferences and other related activities.
Qualifications
Education: Professional Training medium or upper level. University degree is a plus.
Languages: Fluent Spanish and basic-intermediate English (B1)
Experience (years/area): +1 years in lab or industrial processes
Specific Knowledge: basic knowledge of unitary separation operations
Travels: ocasionally
Personal skills: Team player and willingness to learn.