Job Title: Executive / Senior Executive – R&D Upstream Process
Location: Biological E Limited, Shamirpet, Hyderabad
Experience Required: 3 to 5 Years
Education: M.Sc. or B.Tech in Biotechnology
Job Summary:
* We are seeking a dedicated and experienced professional to join our R&D Upstream Process team at Biological E Limited in Shamirpet, Hyderabad.
* The ideal candidate will have 3 to 5 years of hands-on experience in upstream bioprocessing, equipment qualification, and process development.
* The role focuses on managing the end-to-end qualification of new systems, from procurement and vendor selection to commissioning and routine operational readiness.
* You will work closely with cross-functional teams to ensure all R&D activities adhere to rigorous GMP, EHS, and regulatory standards.
* Candidates with strong technical expertise in fermenter operations (small to pilot scale) and laboratory instrumentation are encouraged to apply.
Company Overview
Biological E Limited is a prominent leader in the biopharmaceutical industry, committed to developing high-quality vaccines and pharmaceutical products. Our R&D division is at the forefront of innovation, consistently striving to advance upstream process technologies to meet global health needs. We provide a collaborative, growth-oriented environment where employees are encouraged to excel in their specialized fields.
Role Description
As a member of our R&D Upstream Process team, you will be responsible for bridging the gap between facility engineering and active research. Your role involves active participation in the lifecycle management of laboratory equipment, ensuring that all systems are fully validated and ready for high-performance research applications. You will be instrumental in maintaining the integrity of our experimental processes while adhering to the highest quality benchmarks.
Key Responsibilities
Equipment Qualification and Validation
* Lead the preparation of User Requirement Specifications (URS) for new equipment and systems.
* Facilitate the vendor selection process, including technical evaluations and procurement coordination with engineering and purchase departments.
* Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to ensure equipment meets operational standards.
* Execute and support comprehensive qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Ensure that all qualification activities are documented in accordance with approved Standard Operating Procedures (SOPs) and regulatory guidelines.
* Review all qualification reports and test results to ensure accuracy, completeness, and compliance.
Operational Excellence and Process Support
* Handle and operate various capacities of fermenters, ranging from small-scale models to pilot-scale systems.
* Manage the preparation of inoculum and culture media for reactors with strict adherence to established protocols.
* Maintain the calibration status of all laboratory instruments and equipment prior to the commencement of any study.
* Ensure all equipment is ready for routine operation following the successful handover from the project or validation teams.
* Proficiency in handling essential laboratory instrumentation, including shaker incubators, bio-safety cabinets, centrifuges, spectrophotometers, microscopes, and Laminar Air Flow Units (LAFU).
Compliance and Documentation
* Identify, report, and investigate deviations that occur during qualification or validation activities, ensuring timely closure of corrective actions.
* Maintain meticulous documentation and traceability for all validation and qualification records.
* Actively collaborate with internal stakeholders, including Quality Assurance (QA), Quality Control (QC), Engineering, and Validation teams, to ensure project milestones are met.
* Enforce strict compliance with Good Manufacturing Practices (GMP), Environment, Health, and Safety (EHS) policies, and all company-mandated operational standards.
Qualifications and Required Skills
* Educational Background: A Master of Science degree (M.Sc.) or a Bachelor of Technology (B.Tech) in Biotechnology.
* Experience: 3 to 5 years of relevant experience in an R&D or biopharmaceutical manufacturing environment.
* Technical Skills: Strong understanding of upstream process workflows, bioreactor operations, and equipment validation lifecycles.
* Soft Skills: Excellent analytical skills, strong attention to detail, the ability to work in a multidisciplinary team, and proficiency in maintaining regulatory documentation.
* Regulatory Knowledge: A solid working knowledge of GMP and EHS regulatory requirements is essential.
Why Join Us?
Joining the team at Biological E Limited offers you the chance to work in a state-of-the-art facility alongside some of the brightest minds in the industry. You will be provided with the opportunity to grow your expertise in a fast-paced R&D environment, contributing to projects that have a tangible impact on global healthcare. We prioritize professional development and provide the necessary support for our team members to thrive in their roles.
How to Apply
If you are a passionate professional looking to advance your career in the R&D Upstream Process domain, we would love to hear from you. Please submit your updated CV, highlighting your relevant experience in equipment qualification and upstream operations, to the email address provided below.
Email: [email protected]
Please ensure your application includes a detailed summary of your experience with fermenters and qualification protocols to help us better evaluate your fit for this position. We appreciate your interest in Biological E Limited.