Technical Writer
About the role
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary As a Technical 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. Your primary responsibility is 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. The Technical Writer position requires a strong understanding of packaging equipment and processes, along with the ability to clearly communicate technical concepts to diverse internal and external stakeholders.
Responsibilities
- 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