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Company Description: Established in 1951, Fermenta Biotech Limited (FBL) is a global Vitamin D3 manufacturer with state-of-the-art R&D and manufacturing facilities in Thane, Kullu, and Dahej. FBL also offers niche APIs, enzymes for antibiotic synthesis, and environmental solutions for wastewater management. www.fermentabiotech.com Summary: Fermenta Biotech Limited is looking for an experienced and highly motivated Jr. Executive / Executive to join our Biotech Division. The ideal candidate will have hands-on experience in both upstream and downstream processes, with specific expertise in fermentation and critical shift process handling. This role is integral to the production of high-quality pharmaceutical APIs, and the candidate must possess knowledge of cGMP standards, documentation practices, and sterilization processes. The successful candidate will play a key role in supporting the production team and ensuring the smooth operation of biotech manufacturing processes. Roles & Responsibilities: Upstream and Downstream Process Handling: Manage and monitor both upstream (fermentation) and downstream (purification, recovery, etc.) processes to ensure the smooth production of biotechnological products. Operate and maintain equipment involved in these processes. Fermentation Expertise: Operate fermentation systems, monitor fermentation parameters, and ensure optimal conditions for microbial growth and product yield. Handle fermentation media, inoculation, and harvest processes. Dry Heat Sterilization: Perform dry heat sterilization for equipment, media, and related items as per SOPs to ensure sterile conditions are maintained in the production environment. Critical Shift Process Management: Oversee critical shift operations during fermentation and other biotechnological processes. Ensure processes are running according to predefined protocols and handle any process deviations or issues during shifts. Compliance with cGMP & Documentation: Ensure all activities are conducted in compliance with current Good Manufacturing Practices (cGMP). Maintain and update necessary documentation, including batch records, process logs, and compliance reports. Troubleshooting & Process Optimization: Troubleshoot any issues or deviations in the production processes and provide solutions. Assist in process improvements and optimization activities to enhance production efficiency and yield. Safety & SOP Adherence: Ensure all safety protocols and standard operating procedures (SOPs) are strictly followed during biotech production activities. Participate in training sessions to stay updated on safety, regulatory, and technical advancements. Cross-functional Collaboration: Collaborate with other departments such as Quality Control (QC), Quality Assurance (QA), and Maintenance to ensure the production process runs smoothly and meets the required standards. Qualification & Skill Requirements: Graduate in Science (e.g., Biotechnology, Microbiology, Biochemistry, or related field). Minimum 3 years of proven experience in biotech production, specifically in fermentation and downstream/upstream processing within the pharmaceutical/API industry. Extensive experience in fermentation processes. Hands-on experience with downstream and upstream processing techniques. Thorough understanding of cGMP regulations and documentation requirements. Proficiency in dry heat sterilization and handling critical shift processes. Knowledge of relevant equipment and instrumentation. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work effectively in a team environment. Strong attention to detail and accuracy. Ability to work under pressure and meet deadlines. Adaptability to changing priorities and tasks. Show more Show less
