HTi LLC is hiring: Technical Writer in Travelers Rest
HTi LLC, Travelers Rest, SC, United States
HTI is seeking a Technical Writer for PAI. PAI Pharma is the lead manufacturer and distributor of high-quality, US-made liquid and unit dose prescription and OTC pharmaceuticals. For over 50 years, PAI has been recognized for their dedication to innovation, research, and patient care, providing essential treatments to hospitals and specialty pharmacies across the nation. This is a 3-4 month contract position. What You Need: Bachelor's Degree in Engineering, Packaging Science, or related discipline. 1-2 years of packaging engineering experience within a manufacturing environment, experience within the pharmaceutical industry strongly preferred Understanding of cGMP requirements and basic concepts for liquid dosage manufacturing. What Your Role Will Look Like: The Technical Writer will be a support to the packaging engineer during generation of packaging records and documents required for FDA filings. The Technical Writer will also provide daily commercial support for packaging operations and during packaging process development. Review and approve packaging batch records and change controls to facilitate the launch and commercialization of Private Label products. Ensure documents are aligned with PAI procedures and practices. Prepare and review technical documents for experimental, exhibit, and commercial batches relevant to the packaging process (Protocols, Reports, eCTD sections for FDA submissions). Execute where necessary and coordinate document approval as per PAI procedures/practices. Assist the TS Packaging Engineer in ensuring the safe and compliant packaging of pharmaceutical products. Support activities such as packaging Technology Transfer, process development for new products, and optimization of commercial processes. Work collaboratively with cross-functional teams to assess project scopes and ensure adherence to SOPs, FDA guidelines, DEA regulations, and safety requirements. Aid in the evaluation of existing and new packaging equipment for exhibit and commercial-scale productions. Assist in troubleshooting and investigating packaging processes as needed. INDPRO