Technical Writer

PQE Group; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

PQE Group is seeking a skilled Technical Writer to create high-quality technical documentation in the pharmaceutical field. The role involves collaborating with IT and business stakeholders to ensure accurate and compliant documentation for ERP implementations, aiming to enhance standards in a regulated industry. The ideal candidate will have a strong expertise in technical writing and relevant experience in life sciences.

Qualifications

• Experience creating structured documentation for ERP implementations.
• Familiarity with documentation in a regulated environment.
• Excellent written and verbal communication skills.

Responsibilities

• Collaborate with cross-functional teams to gather information for documentation.
• Develop and maintain SOPs, validation protocols, and user manuals.
• Ensure compliance with GxP and 21 CFR Part 11.

Skills

Document management

Regulatory compliance

Technical writing

Communication

Education

Bachelor’s degree in Technical Writing, Life Sciences, Information Technology

Certifications in technical writing or quality systems (e.g., AMWA, ASQ)

Tools

Kneat software

SAP

Oracle

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

We are seeking a skilled Technical Writer with a strong background in the pharmaceutical industry to support both business and IT stakeholders in the development of high-quality technical and procedural documentation.

You will be responsible for:

• Collaborate with cross-functional teams, including IT and business units, to gather information and translate complex processes into clear, structured documentation
• Develop and maintain technical documentation, including SOPs, validation protocols, user manuals, and training materials
• Ensure all documents comply with regulatory and company standards, including GxP and 21 CFR Part 11 where applicable
• Assist in documentation planning and strategy throughout ERP implementation phases
• Track and manage documentation versions, approvals, and archiving using appropriate tools
• Conduct reviews and updates of existing documentation to reflect changes in processes or systems

About you:

• Proven experience creating structured documentation for ERP implementations (e.g., SAP, Oracle, or similar systems) in the life sciences or pharmaceutical sector
• Familiarity with Kneat software for electronic documentation and validation management is highly desirable
• Strong understanding of documentation practices in a regulated environment (GMP, GCP, GAMP 5)
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple documentation tasks simultaneously
• Bachelor’s degree in Technical Writing, Life Sciences, Information Technology, or a related field
• Certifications in technical writing or quality systems (e.g., AMWA, ASQ) are a plus
• ENG: fluent

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.