Pharma Packaging Technical Writer — Validation & GMP Docs

Alcami-5; Michigan; On-site; USD 65,000 - 85,000; Full time

Job summary

Alcami is seeking a Technical Writer to join our Technical Services team on a 100% on-site, first-shift basis. You will author FDA- and GMP-compliant documentation, including Master Batch Records (MBRs), validation tests for equipment and components, and support qualification activities for new products and validated packaging operations.

The ideal candidate has at least two years of pharma cGMP writing experience, strong communication skills, and proficiency with Office 365 tools.

Qualifications

• Two years of Pharmaceutical cGMP writing experience or equivalent.
• Experience writing technical/validation documentation.
• Bachelor’s degree or equivalent with 5+ years in related role preferred.

Responsibilities

• Develop, author, and support validation protocols including FAT, SAT, IQ/OQ/PQ.
• Create and maintain Master Batch Records (MBRs) and related validation documents.
• Prepare Label Requests and ensure labeling accuracy and traceability.
• Collaborate with Engineering, Quality, Operations, and Production teams.
• Support RCAs, Change Controls, CAPAs, and risk assessments as required.

Skills

Technical writing

Regulatory documentation

Communication

Qualification support

Education

Bachelor's degree or equivalent (5+ years)

Tools

Office 365

Microsoft Teams

Job description

Alcami is seeking a Technical Writer to join our Technical Services team on a 100% on-site, first-shift basis. You will author FDA- and GMP-compliant documentation, including Master Batch Records (MBRs), validation tests for equipment and components, and support qualification activities for new products and validated packaging operations.

The ideal candidate has at least two years of pharma cGMP writing experience, strong communication skills, and proficiency with Office 365 tools.