On-Site Pharma Technical Writer: Validation & Documentation

Alcami Corporation; Clinton (TN); On-site; USD 55,000 - 85,000; Full time

Job summary

Alcami Corporation in Clinton, TN seeks a Technical Writer to develop and maintain validation and manufacturing documentation, ensuring GMP compliance and regulatory traceability.

You will author Master Batch Records, Work Instructions, and labels, supporting validated processes and cross-functional teams including Engineering, Quality, and Operations. Training on new documentation will also be provided.

Qualifications

• At least two years of prior experience in a Pharmaceutical cGMP environment.
• Experience in technical and/or validation writing.
• Bachelor's Degree or equivalent of 5+ years prior experience preferred.

Responsibilities

• Develop, author, and support execution of validation protocols (FAT, SAT, ES, IQ, OQ, PQ).
• Design equipment- and component-specific validation tests.
• Assist with qualification activities and support OQ/PQ for new products.
• Ensure GMP, FDA and customer requirements are met in documentation.
• Create and maintain Master Batch Records, setup sheets, and work instructions.

Skills

Pharma cGMP understanding

Technical writing

Documentation development

Communication skills

Education

Bachelor's degree or equivalent (5+ years experience)

Tools

MS Word

MS Excel

MS Teams

Job description

Alcami Corporation in Clinton, TN seeks a Technical Writer to develop and maintain validation and manufacturing documentation, ensuring GMP compliance and regulatory traceability.

You will author Master Batch Records, Work Instructions, and labels, supporting validated processes and cross-functional teams including Engineering, Quality, and Operations. Training on new documentation will also be provided.