LL01-100424 Biotech Manufacturing Operator (Drug Substance) - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Biotech Manufacturing Operator (Drug Substance)
• Temporary Position: 3 - 6 months (Willing to work at USA and France)

Job Summary:

The Biotech Manufacturing Operator is responsible for executing and monitoring various steps in the production process of drug substances. The operator ensures that all processes are performed in compliance with company policies, industry standards, and Good Manufacturing Practices (GMP). This role involves working with bioreactors, filtration systems, chromatography equipment, and other production technologies commonly used in the biotech industry.

Key Responsibilities:

• Production Operations:
  • Operate, monitor, and troubleshoot equipment used in the production of drug substances, including bioreactors, centrifuges, filtration systems, and chromatography columns.
  • Execute batch records, protocols, and standard operating procedures (SOPs) to ensure efficient and accurate production.
  • Perform sterile operations and aseptic techniques to maintain cleanroom and production environment standards.
• Equipment Maintenance:
  • Perform routine calibration, cleaning, and maintenance of production equipment.
  • Assist in the setup, changeover, and tear-down of manufacturing equipment.
• Process Monitoring and Control:
  • Monitor critical process parameters (e.g., pH, temperature, pressure) and adjust controls to maintain optimal operating conditions.
  • Collect and analyze in-process samples to ensure product quality and process consistency.
• Documentation:
  • Accurately document production activities, process deviations, and maintenance logs in accordance with GMP and regulatory requirements.
  • Complete and review batch production records for completeness and accuracy.
• Quality and Compliance:
  • Ensure compliance with company policies, GMP guidelines, safety protocols, and environmental regulations.
  • • Participate in audits, inspections, and continuous improvement initiatives to enhance product quality and production efficiency.
• Safety and Training:
  • Follow all safety protocols to ensure a safe working environment.
  • Participate in safety and process training sessions to enhance technical skills and knowledge.

Qualifications:

• Education: High school diploma or GED required; Associate’s or Bachelor’s degree in Biotechnology, Biochemistry, or a related field preferred.
• Experience:
  • 1-3 years of experience in a GMP-regulated environment, preferably in biotech or pharmaceutical manufacturing.
  • Experience with upstream (cell culture, fermentation) or downstream (filtration, chromatography) processes is a plus.
• Skills:
  • Strong mechanical aptitude and problem-solving abilities.
  • Attention to detail and the ability to work in a fast-paced, regulated environment.
  • Proficiency with computer systems, including manufacturing execution systems (MES) and electronic batch records (EBR).
  • Familiarity with regulatory requirements such as GMP and FDA standards.
• Work Environment:
  • Must be able to work in a cleanroom environment with exposure to chemicals, biological materials, and machinery.
  • Ability to stand for extended periods and perform repetitive tasks.
  • Willingness to work shifts, weekends, and holidays as required by production schedules.