GMP & FDA Technical Writer: Validation & Docs (On-Site)

Alcami Corporation; Northern (KY, MI); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Alcami Corporation is seeking a Technical Writer to develop FDA- and GMP-compliant documentation supporting pharmaceutical packaging operations, including Master Batch Records (MBRs), validation tests, and qualification activities. The role requires clear communication to diverse stakeholders and collaboration across teams to ensure compliant, traceable documentation in a regulated environment.

The position is on-site with standard daytime hours, focused on on-site execution and continuous

Qualifications

• Minimum two years of experience in a pharmaceutical cGMP environment.
• Experience in technical and/or validation writing.
• Bachelor's Degree or equivalent to 5+ years of related experience preferred.

Responsibilities

• Develop, author, and support validation protocols (FAT, SAT, IQ/OQ/PQ).
• Create and maintain Master Batch Records (MBRs) and Master Setup Sheets/Work Instructions.
• Prepare Label Requests and ensure labeling accuracy and traceability.
• Collaborate with Engineering, Quality, Operations, and Production on cross-functional projects.
• Identify inefficiencies and drive process improvements in validation/documentation.

Skills

Attention to detail

Verbal and written communication

Manufacturing operations familiarity

Education

Bachelor's degree or equivalent of 5+ years experience

Tools

Office 365

Microsoft Teams

Job description

Alcami Corporation is seeking a Technical Writer to develop FDA- and GMP-compliant documentation supporting pharmaceutical packaging operations, including Master Batch Records (MBRs), validation tests, and qualification activities. The role requires clear communication to diverse stakeholders and collaboration across teams to ensure compliant, traceable documentation in a regulated environment.

The position is on-site with standard daytime hours, focused on on-site execution and continuous