Job Description
Job Summary/ Main Purpose
Sr. Production Technician – the role holder is responsible to adhere with the cGMP principles and to maintain them in an effective manner. Follow instructions, ensure that all safety regulations are followed. Responsible for the upstream and downstream operations in the Biotechnology Plant.
Key Responsibilities & Key Result Areas
- Responsible to follow cGMP norms and the Standard Operating Procedures as defined.
- Responsible for doing all Cell culture production activities under supervision.
- Responsible for Monitor cell inoculation, growth, cell expansion for regular production activity.
- Operate and troubleshoot bioreactors and Roller bottle incubator and cell culture systems
- Responsible to work with standard scientific equipment as described for relevant process, Roller bottle incubators, CO2 incubators, biosafety cabinets, centrifuge, autoclaves, weighing balances, pH meter, refrigerators and freezers.
- Prepare buffers and solutions as per MFM / SOP.
- Responsible for cGMP document preparation.
- Perform QMS activity, deviation investigations, root cause analysis, and corrective action/preventative action (CAPA) implementation.
- Fills the production batch records and to ensure the quality standards are met.
- Maintains and operates machinery used in batch manufacturing based on operating procedures.
- Responsible for filling the documents (MFM, Logbooks / attachments).
Core Competency
- Highly oriented with strong sense of accountability & ownership.
- Good communication, interpersonal and collaboration skills required.
- Open for new learnings at the workplace with implementation skills.
- Good on process compliance with time and task management.
- Positive and approachable manner.
- Ability to work under pressure & meet attendance standards.
Qualifications / Key Experiences / Functional Knowledge Requirements
- Bachelor’s degree or diploma in a relevant scientific or engineering field such as Microbiology, Biotechnology, Biochemistry, and chemical engineering required.
- 5+ years’ experience with mammalian cell culture experience
- Understanding of cGMP strongly preferred
- Ability to work with computer controlled systems and proficient with Microsoft Word, Excel, and PowerPoint required Required
- Knowledge of Good Documentation and recording.
