Validation Associate 1

About the role

Sentry BioPharma Services provides pharmaceutical product management for temperature‑sensitive medications, maintaining drug products at specific temperatures, labeling, kitting, packaging, and distributing them to fifty (50) countries. The company’s newest offerings include a full stability program, aliquoting for further testing, and analytics for stability through Sentry Laboratory Services. The Validation Associate I will contribute to validation and qualification processes, ensuring equipment and processes meet the highest standards of quality and compliance while supporting regulatory compliance and continuous improvement.

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, and calibration tasks, including providing 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 (monthly, quarterly, etc.) and note any irregularities.
• Complete validation/qualification/calibration processes in accordance with schedules and timelines.
• Assist in response to alarms and take appropriate actions to correct issues (e.g., contact vendors, make repairs, transfer material).
• 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 and perform additional duties as assigned by the supervisor.
• May be required to travel to attend training or provide support at multiple Sentry locations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 1 to 3 years of experience within validation or a GMP‑regulated environment (preferred).
• 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 written and verbal communication skills.
• Ability to work independently and as part of a team in a fast‑paced environment.
• Experience in the pharmaceutical and/or biotech industry or related field is a plus.