Associate Validation & Qualification

Role purpose

Validation and technology transfer

• Support technology transfer activities, including laboratory, scale-up, exhibit, and validation batches.
• Prepare and review study protocols, technical assessments, and scientific reports for process understanding and product readiness.
• Support technical documentation and responses for regulatory submissions and deliverables.
• Review and approve validation master plans, protocols, and reports for regulatory and company-policy compliance.
• Troubleshoot validation issues with equipment and processes, and analyze test results to address anomalies.
• Write, review, and approve validation documents and technical reports for equipment, products, and processes.
• Determine new equipment process capability using approved protocols and incorporate parameters into procedures and batch records.

Regulatory, project, and training work

• Contribute to project tasks and milestones and organize work to meet deadlines.
• Assist with validation protocol development and manage regulatory queries and responses.
• Participate in deviation investigations, identify root causes, and define corrective and preventive actions.
• Follow company and cGMP procedures and safety regulations, and contribute to validation programs that maintain current standards.
• Collaborate with Quality Operations training leads, coordinators, and subject-matter experts on cGMP and site training initiatives.
• Summarize training data in concise reports for review and approval.

Minimum requirements

• Bachelor's degree with any years of experience; or an associate's degree with 4 years of relevant experience; or a high school diploma or equivalent with 6 years of relevant experience.
• Excellent attention to detail and solid understanding of FDA regulations and guidance and Good Manufacturing Practices.
• Strong organizational skills and ability to manage changing deadlines.
• Proficiency in Microsoft Office, particularly Excel, for data evaluation.
• Strong written and verbal communication; ability to work collaboratively in a team.
• Basic understanding of validation principles and practices.

Preferred requirements

• Technical writing experience, particularly in the pharmaceutical industry.
• Laboratory process validation expertise.
• Working knowledge of equipment qualification and calibration, especially for laboratory equipment.
• Experience with regulatory queries and responses.
• Interpersonal skills, cross-functional collaboration, adaptability, flexibility, and commitment to continuous learning.
• Experience with generative AI tools such as ChatGPT or Microsoft Copilot, curiosity about using them to improve outcomes, and awareness of responsible AI practices.

Work location

• Work Location Assignment: On Premise.