Validation Associate I: GMP Compliance & Quality

Sentry BioPharma Services, Inc.; Indianapolis (IN); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Sentry BioPharma Services, Inc. is seeking a detail-oriented Validation Associate I to join our team in Indianapolis. This role focuses on executing validation protocols (IQ/OQ/PQ), supporting regulatory compliance, and driving continuous improvement in equipment and processes.

The successful candidate will collect and analyze validation data, prepare reports, and collaborate with multiple departments to ensure on-time project completion in a fast-paced biotech/pharma environment.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Experience in validation, qualification, or similar role in regulated environment preferred.
• Knowledge of cGMP, FDA regulations, and validation principles.
• Strong attention to detail and organizational skills.
• Excellent problem-solving and troubleshooting abilities.
• Effective communication skills, both written and verbal.

Responsibilities

• Execute validation protocols (IQ/OQ/PQ) and participate in reports.
• Provide support and troubleshooting for validated/qualified equipment.
• Identify opportunities for process improvements and implement solutions.
• Ensure validation activities comply with cGMP, FDA, and regulatory requirements.
• Collaborate with cross-functional teams to support validation projects.
• May travel to other Sentry locations for training or support.

Skills

Attention to detail

Organizational skills

Problem solving

Troubleshooting

Written and verbal communication

Independent and team work

Education

Bachelor's degree in Life Sciences/Engineering or related field

Job description

Sentry BioPharma Services, Inc. is seeking a detail-oriented Validation Associate I to join our team in Indianapolis. This role focuses on executing validation protocols (IQ/OQ/PQ), supporting regulatory compliance, and driving continuous improvement in equipment and processes.

The successful candidate will collect and analyze validation data, prepare reports, and collaborate with multiple departments to ensure on-time project completion in a fast-paced biotech/pharma environment.