Technical Writer

Job Description

Technical Writer

Title: Technical Writer
Location: Marietta, GA
Industry: Pharmaceutical Manufacturing
Hours: M-F, 8am-5pm
Salary: Competitive compensation package (eligibility up to 10% performance company bonus, 401k, health, dental and vision)
Employment Type: Direct hire

Company Overview:

We re partnering with a fully integrated US based biopharmaceutical organization focused on advancing specialty treatments. With a growing and diverse product pipeline, including complex generics and specialty formulations, this is an opportunity to step into a leadership role where your work directly supports life-changing therapies. If you're a hands-on leader with strong pharmaceutical manufacturing experience, this role offers the chance to drive production excellence, mentor teams, and grow your leadership career in a highly regulated, high-impact environment.

Description:
Create, manage, and oversee the generation of technical documents for the Manufacturing Operations department.

Essential Responsibilities:

• Interact with technical associates, leads and subject matter experts (SMEs) from other departments and divisions to create and revise GMP Manufacturing Batch Records, investigations, change controls, with a strong emphasis on the following pharmaceutical processes (fluid bed granulation, blending, milling, bi-layer compression, encapsulation, coating & packaging.
• Prepare, write, update, and maintain manufacturing SOPs and FORMs where applicable, including the preparation of any forms or attachments that may accompany the SOP.
• Other duties as assigned.

Core Competencies:

• Position requires the ability to work independently, and effective skills in all areas of communication, collaboration, and decision-making.
• Great attention to detail with ability to work on multiple projects.
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
• Computer experience required.
• Proficiency in Microsoft Office (Word, Excel, and Outlook).

Minimum Qualifications:

• Degree (BA/BS) in a technology related field (Biology, Chemistry, Pharmacy, Engineering, etc.) and at least 2-7 years development or manufacturing experience in a cGMP solid dosage manufacturing environment with the ability to understand the fundamental processing stages required to create the initial batch records as well as other supporting documentation (i.e. protocols, change controls, investigations, deviations and final reports).
• One must have pharmaceutical experience; oral solid dosage is highly preferred. May consider other dosage forms.
• Two-five years of technical writing experience.
• This person should possess a pharmaceutical Manufacturing/Development and cGMP background in a solid dosage form environment with preferred background in Bi-layer Tableting Technology, with a clear understanding of compliance, clear, well defined processing steps, logical process flow and an emphasis on Quality processing. This person must have the ability to articulate their point clearly and concisely through the power of written words .
• Strong computer skills are a necessity, with an ability to accurately convey information in both spoken and written form. Strong command of the English language is essential.
• Must meet deadlines and be detail oriented. Solid organizational skills are a necessity, with a demonstrated ability to organize and track several projects simultaneously. The ability to follow-up with multiple departments is required.

ADA/EOE
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