Validation Writer

Job Description

Job Description

Validation Writer

???? Clinton, TN | Full-time | Onsite
???? Department: Technical Services

Tjoapack is a global contract packaging organization (CPO) specializing in primary and secondary pharmaceutical packaging and supply chain management services. With more than 30 years of experience, we process millions of medicine packages every year for customers in over 45 countries worldwide.

Operating in Clinton, TN since 2021, Tjoapack is focused on delivering safe, compliant, and reliable packaging solutions—always with the patient at the center of our supply chain.

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 as an entry level technical writer.

Your primary responsibility is entry level Technical Writing- 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.

One year of prior experience in a cGMP environment is required for consideration.

???? Process & Equipment Validation

• 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.

???? Technical Documentation Development

• 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.

⚙️ Packaging & Component Evaluation

• 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.

???? Project Support & Collaboration

• 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.

???? Continuous Improvement

• 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.

• One year of prior experience in a cGMP environment is required for consideration.
• 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.

• 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.

All employment at Tjoapack is contingent upon successful completion of:

• Background check
• Drug screening
• Physical examination

If you enjoy technical writing, validation work, and supporting regulated manufacturing environments, we’d love to hear from you.