Technical Writer

Catalyx are seeking a technical writer to join our team and work full time onsite on our customer site in Cork

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services.

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

Role Purpose:

The Technical Writer will be embedded onsite our client site and will have primary ownership for the drafting, writing, and coordination of process deviations arising from Packaging and Manufacturing operations.

The role is critical in ensuring deviations are clear, compliant, timely, and inspection-ready, supporting Right First Time documentation, robust root cause analysis, and effective CAPA generation, in line with GMP and site procedures.

Key Responsibilities:

Deviation Ownership & Technical Writing

• Own the end-to-end writing of Packaging and Manufacturing process deviations, from initial documentation through to closure.

• Translate complex technical events into clear, concise, and compliant deviation narratives.

• Ensure deviations accurately reflect what happened, why it happened, and how recurrence will be prevented.

• Partner with SMEs to document root cause analysis, impact assessment, and CAPAs in line with site standards.

• Maintain high standards of data integrity, clarity, and consistency across all deviation records.

Cross-Functional Collaboration

• Work closely with Packaging, Manufacturing, Engineering, and QA teams to gather accurate technical input.

• Facilitate timely deviation progression by proactively following up on actions, approvals, and inputs.

• Act as a documentation subject matter expert, supporting teams with deviation structure, wording, and expectations.

Compliance & Inspection Readiness

• Ensure deviations comply with GMP, regulatory expectations, and site procedures.

• Support inspection readiness by ensuring deviations are complete, defensible, and audit ready.

• Identify recurring themes or documentation gaps and flag trends to QA.

Continuous Improvement

• Contribute to continuous improvement initiatives related to deviation quality, cycle time, and Right First Time metrics.

• Support standardisation of deviation language and structure across Packaging and Manufacturing.

• Provide guidance or informal coaching to operations teams on deviation inputs and expectations.

Requirements:

• Degree in Science, Engineering, or a related discipline.

• Strong experience writing GMP deviations within a regulated pharmaceutical or biopharmaceutical environment.

• Demonstrated experience performing and documenting Root Cause Analysis (RCA) using structured problem solving methodologies ( 5 Whys, Fishbone, Cause and Effect) including linkages to clear and effective CAPAs.

• Demonstrated experience supporting Packaging and/or Manufacturing operations.

• Excellent technical writing skills with the ability to distil complex events into clear, structured documentation.

• Strong working knowledge of GMP and data integrity principles.

• Ability to work fully onsite in a fast-paced operational environment.

• Familiarity with electronic Quality Management Systems (eQMS).

Key Competencies

• Exceptional written communication and attention to detail

• Strong stakeholder engagement and influencing skills

• Ability to work independently and manage multiple deviations simultaneously

• Pragmatic, solutions-focused mindset

• High level of professionalism and discretion

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified

candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.