Senior Validation and Qualification Specialist

Job Overview:

We are seeking a seasoned professional to lead our validation and qualification activities for various areas and facilities, including manufacturing equipment, cold storage equipment, utilities, and aseptic areas.

The ideal candidate will have experience in validation and qualification processes within the pharmaceutical or biotechnology industry, specifically on injectables. They will be responsible for managing the initial and periodic validation and qualification activities, developing and maintaining comprehensive validation and qualification protocols and reports, and ensuring compliance with regulatory requirements and internal SOPs.

The successful candidate will also lead a team of validation and qualification specialists, providing guidance, training, and performance management, and foster a culture of continuous improvement.

About Us:

Our mission is to accelerate access to affordable and innovative medicines because Good Health Can't Wait.

We strive to maintain a work environment free from discrimination and are an equal opportunity employer. We treasure every talent and recognize merit and diversity in our organization.

Key Responsibilities:

• 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
• Manage media fill activities to ensure aseptic conditions are maintained
• Conduct and oversee smoke studies to validate airflow and contamination control in aseptic areas
• Develop and maintain comprehensive validation and qualification protocols and reports
• Evaluate and ensure compliance with regulatory requirements and internal SOPs
• Lead a team of validation and qualification specialists, providing guidance, training, and performance management

Requirements:

• Bachelor's degree in Engineering, MSc or MPharm in Life Sciences, or a related field
• 10-15 years of experience in validation and qualification within the pharmaceutical or biotechnology industry
• 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

About Our Department:

We operate in the Global Biosimilars business, a segment poised for attractive and sustained growth over the next 10-15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering US $80 Bn in innovator sales, future business pipeline covers a variety of product classes and therapy areas, and new modalities.

Fully integrated organization with over two decades of experience in developing, manufacturing, and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities - in-house clone development, upstream and downstream process development, bioanalytical development, and proprietary formulation, supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.

We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure. Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.