Technical Writer: Life Sciences (CPV Reports)

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 author, review, and maintain Continued Process Verification (CPV) reports and related documentation, alongside providing project coordination support for a global CPV improvement initiative for our end client. The CPV documentation will support ongoing process monitoring and improvement initiatives, meet regulatory, scientific, and quality standards, and effectively communicate complex data and trends to cross-functional stakeholders.

KEY RESPONSIBILITIES

CPV Reports

• 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.

• 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.

• 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).

• 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.

Project Coordination

• Support project set-up activities, including project trackers, document repositories, working folders, meeting schedules, review calendars, templates, and administrative controls.

• Maintain action logs, decision logs, milestone trackers, review trackers, RAID log inputs, and other project administration artefacts as directed by the Project Manager or delivery lead.

• Coordinate project meetings, workshops, SME interviews, documentation review sessions, and client touchpoints, including agenda preparation, minute-taking, action capture, and follow-up.

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 or biotech industry.

• Proven experience writing CPV reports or similar process monitoring documentation.

• Experience supporting project coordination activities, including maintaining project trackers and action logs, coordinating meetings, and supporting documentation review schedules.

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).

DESIRABLE REQUIREMENTS

• Understanding of the PPQ process and how PPQ data and findings inform ongoing CPV.

• Experience with CPV programs in biologics or sterile manufacturing environments.

• Familiarity with data visualization tools or dashboards.

• Knowledge of Six Sigma or Lean methodologies.

DEVELOPING REQUIREMENTS

AI and Automation

• Understand foundational AI concepts, including how AI retrieves and processes information.

• Apply best practices to content structure that ensures reliable AI retrieval and generation.

• Apply foundation prompting best practices.

• Create and evaluate content lifecycle process maps.

• Identify and evaluate potential automation opportunities within a content lifecycle or process.

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:

• Getting 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.

• Participation in the Altuent Sick Pay scheme.

• Participation in the VHI/Altuent Group health insurance scheme.

• Participation in the TaxSaver Commuter Ticket scheme.

ABOUT ALTUENT

Altuent helps organisations transform content into trusted knowledge that people and AI can find, understand, and use with confidence.

We partner with leading organisations in life sciences, technology, and other regulated industries to improve how knowledge is created, governed, managed, and delivered. Our expertise spans technical communication, knowledge management, content strategy, AI readiness, information architecture, localisation, learning, and content operations.

As organisations increasingly adopt AI-powered tools and digital experiences, the quality and structure of their content has never been more important. We help our clients build strong content and knowledge foundations that improve compliance, accelerate onboarding and training, support operational excellence, and enable reliable AI outcomes.

Our team combines deep domain expertise with a practical, people-first approach. Whether supporting regulated documentation, knowledge management initiatives, content transformation programmes, or AI-enabled knowledge solutions, we focus on making complex information clear, accessible, and actionable.

Headquartered in Cork, Ireland, with a global team and client base, Altuent is committed to helping organisations unlock greater value from their knowledge while creating an environment where our people can learn, contribute, and grow.

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 failure.