What are the responsibilities and job description for the Technical Writer (Pharmaceutical) position at HTI?
HTI is seeking a Technical Writer for a large manufacturer of prescription and OTC pharmaceuticals. Leveraging cutting-edge technology to produce the best-in-class suspensions and oral solutions, this manufacturer has been recognized for being a leader in innovation, quality, and safety. Understanding it is their employees who make the true impact, this organization is known for their commitment to being an employer of choice - offering competitive pay, benefits, and a positive environment for employees at any level!
What They Offer:
- Full benefits package – Medical, Dental, Vision, EAP, 401k Match
- Onsite Wellness Center
- Tuition Reimbursement
- 13 Paid Holidays
- Progressive PTO Plan
What You Need:
- Associate's degree in Science or Engineering preferred
- 1-2 years of experience within a manufacturing environment, experience within the pharmaceutical industry strongly preferred
- Experience as a Technical Writer in a cGMP regulated environment writing documentation in support of audit and compliance activities is highly desirable.
- Understanding of cGMP requirements and basic concepts for liquid dosage manufacturing.
What Your Role Will Look Like:
The Packaging Technical Writer will be a support to the packaging engineer during generation of packaging records and documents required for FDA filings. The Packaging Technical Writer will also provide daily commercial support for packaging operations and during packaging process development.
- Assist with the preparation of the new packaging batch records and associated change controls to support the Private Label product launches and commercialization and coordinate approval of documents.
- Review and execute the technical documents for batches as applicable to packaging process.
- General documents in compliance with company format and procedures to allow for consistent execution of documents.
- Assist packaging engineer with preparation of documents to support submissions to agency.
- Assist packaging engineer in the safe and compliant packaging of pharmaceutical products as related to packaging Technology Transfer, packaging process development for new products, commercial process optimization, etc.
- Assist and collaborate during investigation and troubleshooting of the packaging processes.
