Company Description
Altuent is an exciting high-growth company. We are a team of technical content creators and consultants supporting leading technology and life sciences companies to create the ideal end-user experience for their internal and external clients.
As knowledge transfer professionals, we are experts in technical writing, eLearning, translation and localization, content strategy, and information for emerging technologies. We are focused on making it easy for our clients to work with us. Whether we're working on Instructions for Use for a medical device, process documentation for developing life-saving drugs, or an online help system for a software application, we guarantee high-quality results and timely delivery.
Our team members enjoy a good benefits package, an open and communicative culture, and opportunities to contribute, learn, grow, and flourish every day in a dynamic environment. We've championed flexible working arrangements, including varied work-from-home options, from our beginning. Altuent was founded on the principle that all communication, no matter how technical, is about people. We put that into practice by making sure that everyone on our team is valued, included, and supported.
Our Values
Our company values give us a framework for leadership and daily decision making, they are what makes Altuent a great place to work. Although we hail from all walks of life and speak dozens of languages, our staff share and work towards a common goal and vision for the company. These values are the embodiment of how we as a company and individually behave and present ourselves both internally and externally to our colleagues and our customers.
* Teamwork
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we support and work for each other.
- Integrity
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we keep our promises.
- Quality
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we are dedicated to excellence.
- Customer focused
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we create value for our customers.
- Making a difference
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we care.
- Measured risk taking
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we learn from successes and failures.
Role Description
We are looking for someone with a background in Pharma / BioPharma or MedTech and experience in GMP documentation, writing, and information design. The successful candidate will support a project with a leading global Biopharmaceutical company.
The Technical Writer will be responsible for authoring, reviewing, and maintaining Continuous Process Verification (CPV) reports and related documentation in support of ongoing process monitoring and improvement initiatives. This role ensures that CPV documentation meets regulatory, scientific, and quality standards, and effectively communicates complex data and trends to cross-functional stakeholders.
Essential Requirements
Education:
* Bachelor's degree or higher in Life Sciences, Engineering, Technical Communication, or related field.
Experience:
* Minimum 3 years of experience in technical writing within the pharmaceutical, biotech, or medical device industry.
* Proven experience writing CPV reports or similar process monitoring documentation.
Skills & Competencies:
* Strong understanding of GMP, ICH Q10, and CPV principles.
* Ability to interpret statistical data and present it in a clear, concise format.
* Excellent written communication and editing skills.
* Proficiency in MS Office Suite, especially Word and Excel; familiarity with statistical tools (e.g., JMP, Minitab) is a plus.
* Experience with electronic document management systems (EDMS).
* Detail-oriented with strong organizational and time-management skills.
Desirable Requirements:
* Experience with CPV programs in biologics or sterile manufacturing environments.
* Familiarity with data visualization tools or dashboards.
* Knowledge of Six Sigma or Lean methodologies.