Technical Writer

Essential Responsibilities: Interact with technical associates, leads, and subject matter experts (SMEs) from Manufacturing Operations, Quality, Validation, Product Support, and other cross-functional groups to create and revise GMP Manufacturing Batch Records, protocols, investigations, deviations, change controls, SOPs, forms, and related technical documentation, with strong emphasis on solid oral dosage manufacturing processes including fluid bed granulation, blending, milling, bi-layer compression, encapsulation, coating, and packaging. Minimum Qualifications: Bachelor s degree (BA/BS) in a technology- or science-related field such as Biology, Chemistry, Pharmacy, Engineering, or a related discipline, with at least 2 7 years of development, manufacturing, or technical documentation experience in a cGMP solid dosage manufacturing environment.

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). Relocation Assistance provided for the right candidate
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 Manufacturing Operations, Quality, Validation, Product Support, and other cross-functional groups to create and revise GMP Manufacturing Batch Records, protocols, investigations, deviations, change controls, SOPs, forms, and related technical documentation, with strong emphasis on solid oral dosage manufacturing processes including fluid bed granulation, blending, milling, bi-layer compression, encapsulation, coating, and packaging.
• Prepare, write, update, and maintain manufacturing SOPs, forms, attachments, and supporting documents, ensuring content is clear, accurate, complete, and aligned with applicable cGMP requirements and site procedures.
• Manage assigned documents through the document lifecycle, including drafting, technical review, comment resolution, approval routing, revision control, and implementation support.
• Translate complex manufacturing, process, equipment, and quality information into logical, user-friendly instructions that support consistent execution, compliance, training, and audit readiness.
• Review technical documents for clarity, consistency, formatting, grammar, data accuracy, procedural flow, and alignment with approved templates and good documentation practices.
• Collaborate with stakeholders to obtain required input, resolve documentation gaps, track deliverables, and ensure assigned documents are completed within established timelines.
• Support continuous improvement of documentation practices by identifying opportunities to improve document structure, usability, consistency, and compliance.
• Perform other duties as assigned.

Core Competencies:

• Ability to work independently and collaboratively while exercising sound judgment, effective communication, and appropriate decision-making.
• Strong attention to detail with the ability to manage multiple priorities, meet deadlines, and maintain accuracy under time-sensitive conditions.
• Ability to organize work, adapt to changing business priorities, follow up with stakeholders, and drive documentation activities to completion with minimal supervision.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and other applicable document management or quality system tools.
• Demonstrated ability to write clear, concise, technically accurate, and grammatically correct documentation for a regulated manufacturing environment.
• Working knowledge of cGMP expectations, good documentation practices, document control, and cross-functional review processes.

Minimum Qualifications:

• Bachelor s degree (BA/BS) in a technology- or science-related field such as Biology, Chemistry, Pharmacy, Engineering, or a related discipline, with at least 2 7 years of development, manufacturing, or technical documentation experience in a cGMP solid dosage manufacturing environment.
• Two to five years of technical writing experience, preferably supporting GMP manufacturing, Product Support, Quality, Validation, or related pharmaceutical operations.
• Experience creating or revising GMP documentation such as batch records, protocols, SOPs, forms, change controls, investigations, deviations, and final reports.
• Knowledge of solid oral dosage manufacturing processes and supporting documentation requirements, with preferred experience in bi-layer tableting technology.
• Ability to understand manufacturing process flow, compliance requirements, quality expectations, and the level of detail needed to produce clear, well-defined, and inspection-ready documentation.
• Strong written and verbal communication skills, including a strong command of the English language and the ability to clearly and concisely convey technical information.
• Strong organizational skills, demonstrated follow-up with multiple departments, and the ability to track several projects simultaneously while meeting deadlines and maintaining attention to detail.

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