Validation Associate 1 in Indianapolis, Indiana at Sentry BioPharma Services Inc

Sentry BioPharma Services provides pharmaceutical product management for temperature sensitive medications. Sentry maintains drug products at specific temperatures, labels, kits, packages and distributes these products into and out of fifty (50) countries for a wide variety of pharmaceutical companies. Sentry’s newest product offerings include a full stability program, aliquoting for further testing and analytics for stability via its laboratory operations at Sentry Laboratory Services.

We are seeking a detail-oriented and proactive Validation Associate I to join our team. This role offers an exciting opportunity to contribute to the validation and qualification processes that ensure our equipment and processes meet the highest standards of quality and compliance. The successful candidate will play a vital role in executing validation protocols, supporting regulatory compliance, and driving continuous improvement within our operations.

Key Responsibilities:

• Execute approved validation protocols, including Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
• Participate in the generation and review of validation and qualification reports to ensure accuracy and completeness.
• Provide support and troubleshooting for all validated and qualified equipment to maintain optimal performance.
• Identify opportunities for process improvements and assist in implementing effective solutions.
• Ensure all validation activities are conducted in compliance with cGMP, FDA, and other applicable regulatory requirements.
• Collaborate with cross-functional teams to support validation projects and ensure timely completion.

Essential Duties & Responsibilities:

Perform validation/ qualification/ calibration tasks, including but not limited to:

• Provide input for development of validation/qualification protocols.
• Collect and analyze data from validation/qualification studies and prepare reports summarizing findings and recommendations.
• Conduct testing and validation/qualification/calibration procedures to ensure compliance with regulatory requirements and industry standards.
• Maintain accurate and complete documentation of validation activities, including protocols, reports, and other relevant documents.
• Trend data from storage environments, i.e. Monthly, Quarterly, etc., noting any irregularities.
• Complete validation/qualification/calibration processes in accordance with schedules and timelines.
• Assist in response to alarms and take the appropriate actions to correct issues (i.e.: contact vendors, make repairs, transfer material physically, etc).
• Report any process or quality problems regarding validated/qualified equipment and implement approved corrective actions.
• Comply with all Standard Operating Procedures (SOP) for business needs.
• Identify and define project and process improvement opportunities.
• Follow biotech/pharmaceutical industry standards and applicable regulations in generating and updating required documentation.
• Assist other departments as needed.
• Additional duties as assigned by supervisor.
• May be required to travel to attend training or provide support at multiple Sentry locations.

Join our innovative organization committed to quality and continuous improvement. We offer a collaborative work environment, opportunities for professional growth, and a comprehensive benefits package. If you are passionate about quality assurance and regulatory compliance, we encourage you to apply.

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Prior experience in validation, qualification, or a similar role within a 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.
• Ability to work independently and as part of a team in a fast-paced environment.
• 1 to 3 years of experience within validation or a GMP-regulated environment is preferred.
• Experience in the pharmaceutical and/or biotech industry or related field is a plus.