Team Member - Validation (Temperature Mapping)

Rsponsible for managing the initial and periodic validation and qualification activities for various areas and facilities. This includes drug substance and drug product manufacturing equipment, cold storage equipment, utilities, media fill of aseptic areas, and smoke studies. The role requires a seasoned professional with experience in validation and qualification processes within the pharmaceutical or biotechnology industry, specifically on injectables.

Key Responsibilities:

1. Validation and Qualification Management

   :
   • Manage the validation and qualification activities for manufacturing equipment such as Autoclaves, Tunnels, Lyophilizers, Bioreactors, and Dry-heat Sterilizers.
   • Handle the validation and qualification of cold storage equipment including Cold Rooms, Deep Freezers, Refrigerators, Incubators, Blast Freezers, Freeze-Thaw units, and Warehouse storage areas.
   • Ensure the validation and qualification of utilities such as Water systems, Compressed air, Nitrogen, Oxygen, and Carbon Dioxide systems.

2. Aseptic Area Management

   :
   • Manage media fill activities to ensure aseptic conditions are maintained.
   • Conduct and oversee smoke studies to validate airflow and contamination control in aseptic areas.

3. Documentation and Compliance

   :
   • Develop and maintain comprehensive validation and qualification protocols and reports.
   • Ensure all activities comply with regulatory requirements and internal SOPs.
   • Maintain accurate and detailed records of all validation and qualification activities.

4. Team Leadership

   :
   • Lead a team of validation and qualification specialists, providing guidance, training, and performance management.
   • Foster a culture of continuous improvement and ensure the team stays updated with the latest industry standards and practices.

5. Project Management

   :
   • Plan, coordinate, and execute validation and qualification projects within defined timelines and budgets.
   • Collaborate with cross-functional teams including Quality Assurance, Manufacturing and Engineering.

6. Risk Management

   :
   • Identify potential risks in validation and qualification processes and develop mitigation strategies.
   • Conduct risk assessments and ensure corrective and preventive actions are implemented effectively.

7. Continuous Improvement

   :
   • Drive continuous improvement initiatives to enhance validation and qualification processes.
   • Stay abreast of industry trends, regulatory changes, and technological advancements.

• Education

  : Bachelor’s degree in Engineering, MSc or MPharm (Life Sciences), or a related field.

• Experience

  : 10-15 years of experience in validation and qualification within the pharmaceutical or biotechnology industry.

• Skills

  :
  • Strong knowledge of validation and qualification principles and practices.
  • Excellent leadership and team management skills.
  • Proficiency in regulatory requirements and industry standards (e.g., FDA, EMA, GMP).
  • Strong project management and organizational skills.
  • Excellent communication and interpersonal skills.
  • Ability to analyze complex data and make informed decisions.

Additional Requirements:

• Ability to work in a fast-paced, dynamic environment.
• Strong problem-solving skills and attention to detail.

About the DepartmentBiologics