Validation Writer

Validation Writer (Entry Level Technical Writer)
📍 Clinton, TN | Day Shift | Full-time
💼 Vacancies: 1

About Tjoapack
Tjoapack is a global contract packaging organization (CPO) specializing in primary and secondary pharmaceutical packaging and supply chain management. 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.

The Role
As a Validation Writer, you are responsible for developing and maintaining technical and validation documentation that supports pharmaceutical packaging operations and ensures compliance with GMP and customer requirements.

This role owns the creation of Master Batch Records, validation protocols, and supporting documentation while collaborating closely with Technical Services, Quality, Production, and project teams to ensure equipment, processes, and packaging components are validated, efficient, and production-ready.

What You’ll Do

📝 Technical Documentation & Validation
• Author, revise, and maintain Master Batch Records (MBRs) aligned with approved processes and regulatory requirements.
• Develop validation protocols and reports, including FAT, SAT, IQ, OQ, and PQ.
• Create Work Instructions, Master Setup Sheets, and supporting production documentation.
• Ensure all documentation supports validated, efficient, and compliant operations.

⚙️ Process & Equipment Validation
• Support execution of equipment and process qualification activities.
• Ensure packaging equipment and processes meet GMP and customer expectations.
• Assist in designing validation testing for new products and equipment.

📦 Packaging & Component Evaluation
• Perform technical evaluations of packaging components and processes.
• Assess and document the impact of changes on packaging and serialization activities.
• Support specification development and component alignment with production needs.

🏷️ Labeling & Documentation Control
• Prepare label requests and ensure labeling accuracy, traceability, and compliance.
• Maintain documentation updates driven by change control, validation outcomes, and continuous improvement efforts.
• Coordinate documentation approvals and updates with internal teams and customers.

🤝 Collaboration & Continuous Improvement
• Partner with Quality, Production, Technical Services, and Project Management teams.
• Participate in cross-functional projects and support implementation of process improvements.
• Contribute to continuous improvement initiatives, including CAPA, RCA, and change control activities.

What We’re Looking For
• 1–3 years of experience in pharmaceutical or regulated manufacturing environments.
• Technical writing experience (required).
• Working knowledge of cGMP principles or ability to complete required training.
• Experience with packaging equipment and components (manual and automated systems).
• Strong attention to detail and ability to manage multiple priorities.
• Proficiency with Microsoft Office (Word, Excel) and Teams.
• Strong communication skills and ability to translate technical concepts clearly.
• Experience with component evaluation and TOPs preferred.

Why Join Us?
• Play a key role in developing documentation critical to compliant pharmaceutical packaging.
• Work cross-functionally with technical, quality, and production teams.
• Gain exposure to validation, serialization, and packaging technologies.
• Be part of a growing site with opportunities for career development.
• Competitive compensation and benefits.

Pre-Employment Requirements ⚕️
All employment at Tjoapack is contingent upon successful completion of:
• Background check
• Drug screening
• Physical examination

Apply Now
If you enjoy technical writing, working with cross-functional teams, and supporting validated pharmaceutical operations, we’d love to hear from you!