PharmEng Technology

Technical Writer

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking experienced Technical Writers for a role in Wake County, NC.

​Objectives of this Role

  • Create new or revise existing content for SOPs, batch records, technical documents associated with a manufacturing process to a high degree of quality in accordance with cGMP requirements and corporate guidelines.
  • Work collaboratively with a project team members including manufacturing, engineering, process development, quality and other subject matter experts to solidify content.
  • Composing product quality compliant handling documentation including but not limited to Standard Operating Procedures (SOPs), work instructions and training materials.
  • Reading existing documentation and other material to become familiar with current and desired future state processes.
  • Adhering to Good Documentation Practices (GDPs).
  • Some independent work will be necessary to gather information via interviewing/interacting with Quality personnel to author documents.
  • Assuring authored documents are in compliance with documentation control and training requirement.

Skills and Qualifications

  • Bachelor’s Degree, Preferably in a Scientific or Technical Field.
  • Must have 2 to 5 years of related experience in technical writing.
  • Technical writing experience in an FDA regulated industry environment required, preferably in biotechnology industry.
  • Must have prior experience authoring GMP documents such as SOPs, and validation documents, etc.
  • Knowledge of GDP required.
  • Exceptional written and verbal communication skills, attention to detail.
  • Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
  • Skilled at organizing information into a clear and concise written form.
  • Ability to work independently as well as in a team environment.
  • Good command of MS Office Suite (Word, Excel, PowerPoint, and Outlook).

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

What We Have:

  • Comprehensive benefits package & competitive wages
  • A supportive environment where employee growth is promoted
  • PTO & paid holidays
  • Other great incentives

Company Response to Covid-19

While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

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Made with ♥ in Philly.