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Technical Writer: Life Sciences
4 weeks ago
THE POSITION
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.
WHAT'S IN IT FOR YOU?
When you join our team, you will become part of an open and communicative culture.
Altuent was founded on the principle that all communication, no matter how technical, is about people.
We put that into practice by ensuring everyone on our team is valued, included, and supported.
We also offer you:
Career progression opportunities in the form of:
A curated learning and development plan that helps you to grow and achieve your career goals.
The opportunity to get involved in projects outside of your area of expertise.
We pride ourselves in creating opportunities for our team members to gain experience in activities and fields that they are interested in.
A good benefits package that consists of:
The opportunity to participate in the company pension scheme.
The opportunity to participate in the company bonus scheme.
Participation in the Altuent Sick Pay scheme.
Participation in the VHI/Altuent Group health insurance scheme.
Participation in the TaxSaver Commuter Ticket scheme.
TASKS
Collate and graph data: Extract specific batch data for analysis and graph appropriately against defined specification and action limits.
Data Interpretation: Translate statistical outputs (e.g., control charts, distribution charts and capability indices) into clear narratives for technical and non-technical audiences.
Collaborate with SMEs: Work closely with Process Engineers, Data Analysts, Quality Assurance, and MS&T teams to gather technical input and interpret data.
Co-ordinate CPV investigations as needed and perform risk analysis.
Author CPV Reports: Write and format CPV reports based on statistical data, process trends, and manufacturing performance, detailing any investigations carried out and ensuring clarity, accuracy, and regulatory compliance.
Ensure Regulatory Compliance: Align documentation with current GMP standards, ICH guidelines, and internal SOPs.
Document Management: Maintain version control, manage the review and approval process and ensure timely updates of CPV documentation in electronic systems (e.g., Veeva, Documentum).
Project Management: Maintain and update data and report trackers and schedules to ensure all CPV reports are completed on time.
Contribute to weekly status reports and attend and present at regular update meetings.
Support Audits and Inspections: Provide documentation support during internal and external audits, including responding to queries related to CPV reports.
Continuous Improvement: Contribute to the refinement of CPV reporting templates, style guides, and documentation practices.
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.
ABOUT ALTUENT
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 -
we support and work for each other.
Integrity -
we keep our promises.
Quality -
we are dedicated to excellence.
Customer focused –
we create value for our customers.
Making a difference –
we care.
Measured risk taking –
we learn from successes and failures.
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