Technical Writer

Alcami Corporation•Clinton, TN

7d•Onsite

About The Position

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. 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.

Requirements

At least two years of prior experience in a Pharmaceutical cGMP environment is required for consideration.
Experience in technical and/or validation writing.
Strong attention to detail and ability to follow regulatory requirements.
Excellent verbal and written communication skills.
Proficiency with Office 365 (Word, Excel) and Microsoft Teams.
Familiarity with manufacturing operations and production support.
Ability to manage multiple priorities and meet timelines in a regulated environment.

Nice To Haves

Bachelor's Degree or equivalent of 5+ years prior experience in related position preferred.

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 customer requirements.
Create and maintain product-specific Master Batch Records (MBRs).
Develop Master Setup Sheets and Work Instructions supporting validated processes.
Prepare Label Requests and ensure labeling accuracy and traceability.
Ensure documentation supports efficient, compliant, and validated production.
Perform technical evaluations of packaging components and processes.
Assess and document the impact of changes to packaging and serialization processes as they relate to validation and documentation requirements.
Participate in cross-functional projects related to product introductions, validation, and process changes.
Collaborate with Engineering, Quality, Operations, and Production teams.
Support training of teams on new documentation, processes, or technologies as needed.
Identify inefficiencies in validation or documentation processes.
Propose and implement process improvements.
Support or initiate RCAs, Change Controls, CAPAs, Risk Assessments, and Validation activities in accordance with procedures.