Validation Writer

Tjoapack • Clinton, TN

14d • Onsite

About The Position

As a Validation Writer, you are a key member of the Technical Services team, responsible for developing FDA- and GMP-compliant documentation supporting primary and secondary pharmaceutical packaging operations.

Your primary responsibility is authoring product-specific Master Batch Records (MBRs) executed during production, as well as equipment- and component-specific validation tests. You will also assist with the execution of qualification activities as needed, supporting new product introductions and validated packaging operations.

This role requires a strong understanding of packaging equipment and processes, along with the ability to clearly communicate technical concepts to diverse internal and external stakeholders.

Requirements

• Understanding of basic cGMP principles (or ability to complete required training).
• 1–3 years of hands-on experience with packaging components and manual or high-speed packaging equipment.
• Experience in technical and/or validation writing.
• Strong attention to detail and ability to follow regulatory requirements.
• Excellent verbal and written communication skills.
• Proficiency with Office 365 (Word, Excel) and Microsoft Teams.
• Familiarity with manufacturing operations and production support.
• Ability to manage multiple priorities and meet timelines in a regulated environment.

Responsibilities

• Develop, author, and support execution of validation protocols including FAT, SAT, Engineering Studies (ES), IQ, OQ, and PQ.
• Design equipment- and component-specific validation tests.
• Assist with the execution of qualification activities as required.
• Support Operational and Performance Qualifications for new products introduced to the facility.
• Ensure equipment and processes meet GMP, FDA, and customer requirements.
• Create and maintain product-specific Master Batch Records (MBRs).
• Develop Master Setup Sheets and Work Instructions supporting validated processes.
• Prepare Label Requests and ensure labeling accuracy and traceability.
• Ensure documentation supports efficient, compliant, and validated production.
• Perform technical evaluations of packaging components and processes.
• Assess and document the impact of changes to packaging and serialization processes as they relate to validation and documentation requirements.
• Participate in cross-functional projects related to product introductions, validation, and process changes.
• Collaborate with Engineering, Quality, Operations, and Production teams.
• Support training of teams on new documentation, processes, or technologies as needed.
• Identify inefficiencies in validation or documentation processes.
• Propose and implement process improvements.
• Support or initiate RCAs, Change Controls, CAPAs, Risk Assessments, and Validation activities in accordance with Tjoapack procedures.

Benefits

• Play a critical role in supporting compliant, validated packaging operations.
• Work cross-functionally with Engineering, Quality, and Production teams.
• Gain exposure to new product introductions and pharmaceutical packaging validation.
• Be part of a growing global organization with long-term stability.
• Competitive compensation and benefits with opportunities for growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 11-50 employees