Technical Writer

<p><span style="font-family: Arial;">Catalyx</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">are</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">seeking</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a technical writer</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">join</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">our</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">team</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">and</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">work</span><span style="font-family: Arial;"> full time onsite </span><span style="font-family: Arial;">on</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">our</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">customer site in Cork</span></p><p><br></p><p><strong><span style="font-family: Arial; color: windowtext;">Who</span><span style="font-family: Arial;"> </span><span style="font-family: Arial; color: windowtext;">We Are:</span></strong></p><p><span style="font-family: Arial;">Catalyx</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">specializes</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">in</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">the</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">science</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">of</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">operational</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">processes.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">With</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">footprint</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">across</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">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.</span></p><p><span style="font-family: Arial;">Catalyx</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">is</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">trusted</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">partner</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">in</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">delivering</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">world-class</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">lifecycle</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">services</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">regulated</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">and</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">highly</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">regulated organisations,</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to empower</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">them</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to enhance efficiency, and drive success.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">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 </span><a href="http://www.catalyx.ai" style="color: rgb(59, 130, 246); text-decoration: underline;"><span style="font-family: Arial; color: windowtext;">www.catalyx.ai</span></a><a href="http://www.catalyx.ai/" style="color: rgb(59, 130, 246); text-decoration: underline;"><span style="font-family: Arial; color: windowtext;">.</span></a></p><p><br></p><p><strong><span style="font-family: Arial;">Role Purpose:</span></strong></p><p><span style="font-family: Arial;">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.</span></p><p><br></p><p><span style="font-family: Arial;">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.</span></p><p><br></p><p><strong><span style="font-family: Arial;">Key Responsibilities:</span></strong></p><p><br></p><p><span style="font-family: Arial;"><u>Deviation Ownership & Technical Writing</u></span></p><ul><li><p><span style="font-family: Arial;">Own the end-to-end writing of Packaging and Manufacturing process deviations, from initial documentation through to closure.</span></p></li><li><p><span style="font-family: Arial;">Translate complex technical events into clear, concise, and compliant deviation narratives.</span></p></li><li><p><span style="font-family: Arial;">Ensure deviations accurately reflect what happened, why it happened, and how recurrence will be prevented.</span></p></li><li><p><span style="font-family: Arial;">Partner with SMEs to document root cause analysis, impact assessment, and CAPAs in line with site standards.</span></p></li><li><p><span style="font-family: Arial;">Maintain high standards of data integrity, clarity, and consistency across all deviation records.</span></p></li></ul><p><span style="font-family: Arial;"><u>Cross-Functional Collaboration</u></span></p><ul><li><p><span style="font-family: Arial;">Work closely with Packaging, Manufacturing, Engineering, and QA teams to gather accurate technical input.</span></p></li><li><p><span style="font-family: Arial;">Facilitate timely deviation progression by proactively following up on actions, approvals, and inputs.</span></p></li><li><p><span style="font-family: Arial;">Act as a documentation subject matter expert, supporting teams with deviation structure, wording, and expectations.</span></p></li></ul><p><span style="font-family: Arial;"><u>Compliance & Inspection Readiness</u></span></p><ul><li><p><span style="font-family: Arial;">Ensure deviations comply with GMP, regulatory expectations, and site procedures.</span></p></li><li><p><span style="font-family: Arial;">Support inspection readiness by ensuring deviations are complete, defensible, and audit ready.</span></p></li><li><p><span style="font-family: Arial;">Identify recurring themes or documentation gaps and flag trends to QA.</span></p></li></ul><p><span style="font-family: Arial;"><u>Continuous Improvement</u></span></p><ul><li><p><span style="font-family: Arial;">Contribute to continuous improvement initiatives related to deviation quality, cycle time, and Right First Time metrics.</span></p></li><li><p><span style="font-family: Arial;">Support standardisation of deviation language and structure across Packaging and Manufacturing.</span></p></li><li><p><span style="font-family: Arial;">Provide guidance or informal coaching to operations teams on deviation inputs and expectations.</span></p></li></ul><p><strong><span style="font-family: Arial;">Requirements:</span></strong></p><ul><li><p><span style="font-family: Arial;">Degree in Science, Engineering, or a related discipline.</span></p></li><li><p><span style="font-family: Arial;">Strong experience writing GMP deviations within a regulated pharmaceutical or biopharmaceutical environment.</span></p></li><li><p><span style="font-family: Arial;">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.</span></p></li><li><p><span style="font-family: Arial;">Demonstrated experience supporting Packaging and/or Manufacturing operations.</span></p></li><li><p><span style="font-family: Arial;">Excellent technical writing skills with the ability to distil complex events into clear, structured documentation.</span></p></li><li><p><span style="font-family: Arial;">Strong working knowledge of GMP and data integrity principles.</span></p></li><li><p><span style="font-family: Arial;">Ability to work fully onsite in a fast-paced operational environment.</span></p></li><li><p><span style="font-family: Arial;">Familiarity with electronic Quality Management Systems (eQMS).</span></p></li></ul><p><strong><span style="font-family: Arial;">Key Competencies</span></strong></p><ul><li><p><span style="font-family: Arial;">Exceptional written communication and attention to detail</span></p></li><li><p><span style="font-family: Arial;">Strong stakeholder engagement and influencing skills</span></p></li><li><p><span style="font-family: Arial;">Ability to work independently and manage multiple deviations simultaneously</span></p></li><li><p><span style="font-family: Arial;">Pragmatic, solutions-focused mindset</span></p></li><li><p><span style="font-family: Arial;">High level of professionalism and discretion</span></p></li></ul><p><strong><span style="font-family: Arial; color: windowtext;">Why</span><span style="font-family: Arial;"> </span><span style="font-family: Arial; color: windowtext;">Join </span><span style="font-family: Arial;">Catalyx?</span></strong></p><p><span style="font-family: Arial;">At Catalyx we understand that our people are our greatest asset. For this reason and many others,</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">we</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">take</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">care</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">of</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">them.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">The</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">team</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">in</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Catalyx</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">benefits</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">from</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Total</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Rewards</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">package.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">This includes great personal benefits and professional growth opportunities.</span></p><p><span style="font-family: Arial;">Catalyx</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">is</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">an</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Equal</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Opportunity</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Employer.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">We</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">are</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">committed</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">creating</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">diverse</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">and</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">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</span></p><p><span style="font-family: Arial;">candidates,</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">regardless</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">of</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">background,</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">and</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">strive</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">to</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">create</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">a</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">welcoming</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">environment</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">for </span><span style="font-family: Arial;">everyone.</span></p><p><span style="font-family: Arial;">At Catalyx, we are committed to attracting the best global talent. We proudly support our international</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">employees</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">by</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">offering</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">assistance</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">with</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Critical</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Skills</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Visa</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">applications</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">for</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">eligible </span><span style="font-family: Arial;">candidates.</span></p><p><br></p>