Senior Aseptic Process Validation Lead

INCOG BioPharma Services; Fishers (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

INCOG BioPharma Services in Fishers, Indiana, is seeking a Senior Quality Process Validation Specialist to oversee QA activities across validation processes. The role demands experience in process performance qualification and compliance with regulatory standards.

The ideal candidate will possess a strong background in pharmaceuticals, with at least 5 years of experience directly involved in process validation. This position requires a thorough understanding of relevant regulatory guidelines and the ability to manage validation protocols efficiently.

Qualifications

• 5+ years of experience in process validation activities in pharmaceuticals.
• Hands-on experience designing and executing validation protocols.
• Working knowledge of regulatory requirements (FDA, EMA, ICH).

Responsibilities

• Provide QA oversight on process validation activities.
• Review approval documents for compliance and regulatory adherence.
• Conduct oversight of change controls related to process validation.

Skills

Process validation expertise

Regulatory compliance knowledge

Statistical process monitoring

Aseptic processing experience

Deviation investigation skills

Education

Bachelor’s degree in a relevant field

Tools

Minitab

JMP

Job description

INCOG BioPharma Services in Fishers, Indiana, is seeking a Senior Quality Process Validation Specialist to oversee QA activities across validation processes. The role demands experience in process performance qualification and compliance with regulatory standards.

The ideal candidate will possess a strong background in pharmaceuticals, with at least 5 years of experience directly involved in process validation. This position requires a thorough understanding of relevant regulatory guidelines and the ability to manage validation protocols efficiently.