Manufacturing Executive - Reagent Manufacturing

Job Title: Manufacturing Executive - Reagent Manufacturing  Location: Bangalore Company Overview: Cambrian designs and manufactures automated medical devices for precision diagnostics. We are dedicated to innovation, quality, and compliance in all aspects of our operations. Key Responsibilities:

• Prepare buffers and solutions according to pre-approved standard operating procedures (SOPs) and batch production records.
• Measure and weigh chemicals with precision using calibrated equipment.
• Accurately measure, mix, and prepare reagents according to standardized Formulation, procedures, and specifications.
• Perform Buffer Filtration. Monitor and adjust pH levels, as required, ensuring compliance with batch specifications.
• Assist in investigations and deviations related to buffer preparation processes.
• Operate within a classified cleanroom environment while adhering to proper aseptic techniques and gowning procedures.
• Maintain cleanliness of the workspace, ensuring compliance with GMP, GLP and ISO standards
• Perform manufacturing operations, such as automation machine setup & functional checks, periodic inspection of filling, and packaging, in a controlled clean room environment following standard work instructions.
• Adhere to strict gowning and de-gowning procedures to maintain cleanliness and prevent contamination of the clean room environmen t.
• Handle and transport materials, components, and finished products within the clean room environment, following proper procedures to prevent contamination and maintain product integrity
•   Ensuring that the manufactured products meet quality standards by conducting visual inspections, measurements, and other quality checks as per SOP throughout the manufacturing process.
• I dentifying and addressing any issues that arise during the manufacturing process, such as equipment malfunctions or deviations from quality standards
• Performing routine maintenance and cleaning of production equipment to ensure optimal performance.
• Accurately complete manufacturing documentation, including batch records, log sheets, and inspection reports, to ensure traceability and compliance with regulatory requirements.
• Contributing to continuous improvement efforts by suggesting process enhancements, participating in problem-solving initiatives
•   Adhere to safety protocols, clean room procedures, and regulatory guidelines, including Good Manufacturing Practices (GMP), Good documentation practices (GDP) and ISO standards, to ensure a safe working environment and product quality.

Cleanroom Awareness and Knowledge Requirements:

• Comprehensive understanding of cleanroom classifications and respective standards.
• Adherence to aseptic techniques and sterile gowning procedures to maintain environmental integrity.
• Awareness of contamination sources (e.g., particulates, microbes) and methods to prevent them.
• Awareness of chemical handling procedures, including storage, labeling, and disposal within a controlled environment.
• Understanding of cleanroom behavior, such as minimizing movement, avoiding unnecessary contact, and following approved workflows.
• Compliance with entry and exit procedures, including airlock systems and gowning requirements.
• Commitment to ensuring that all processes within the cleanroom meet the highest standards for product hygiene and integrity.
• Execution of environmental monitoring and in-process quality checks to verify cleanliness and compliance.
• Awareness of the impact of personal and procedural hygiene on product safety and customer trust.

QUALIFICATION:

• Bachelors in Biotechnology/Biochemistry or equivalent is typically required.
• F amiliarity with clean room protocols, gowning procedures, and cleanliness standards.
• 2-3 yrs of Experience in IVD or other related field
• Previous experience in buffer preparation, cleanroom operations is mandatory.
• Pr ior experience in manufacturing, Automated filling machinery. Experience in the medical device industry will be preferred.

Physical requirements: · M anufacturing executives may need to stand for extended periods, lift heavy objects, and perform repetitive tasks. Languages required: · Kannada · English Benefits: Competitive salary commensurate with experience. Comprehensive benefits package including medical, dental, and vision coverage. 401(k) retirement plan with company match. Paid time off and holidays. Opportunities for professional development and advancement within the company.