Manufacturing Operations Specialist

17 hours ago

Bengaluru, Karnataka, India Cambrian Bioworks Full time

About Cambrian Bioworks

Cambrian Bioworks designs and manufactures cutting-edge medical devices for precise diagnostics. We pride ourselves on innovation, quality, and compliance in all aspects of our operations.

Job Overview

We are seeking an experienced Manufacturing Operations Specialist to lead production excellence at our Bangalore facility. As a key member of our team, you will be responsible for overseeing the preparation of buffers and solutions, operating automated machinery, and ensuring adherence to strict cleanliness standards.

Key Responsibilities:

  • Buffer Preparation and Solution Management
  • 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 environment.
  • Handle and transport materials, components, and finished products within the clean room environment, following proper procedures to prevent contamination and maintain product integrity
  • Ensure that manufactured products meet quality standards by conducting visual inspections, measurements, and other quality checks as per SOP throughout the manufacturing process.
  • Identify and address any issues that arise during the manufacturing process, such as equipment malfunctions or deviations from quality standards
  • Perform 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.
  • Contribute 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.

Qualifications and Experience:

  • Bachelor's degree in Biotechnology, Biochemistry, or equivalent is typically required.
  • Familiarity with clean room protocols, gowning procedures, and cleanliness standards.
  • 2-3 years of experience in IVD or related field.
  • Previous experience in buffer preparation, cleanroom operations is mandatory.
  • Prior experience in manufacturing, automated filling machinery, and experience in the medical device industry is preferred.

Physical Requirements:

Long hours standing may be necessary, along with heavy lifting, and repetition of tasks.

Languages Required:

Kannada and English language skills are essential.

Benefits:

We offer a competitive salary of ₹70 lakhs annually, commensurate with experience, along with a 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.

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