Manufacturing Technical Support Specialist

Catalyx are seeking a Manufacturing Tech Support Specialist to join our team on our customer site in Cork. This role will involve collaboration with EHS teams as well as SMEs to draft, review and update risk assessments for manufacturing processes. The ideal candidate will have strong technical writing capabilities, keen attention to detail and proficiency in handling documentation in within a regulated environment. This is a days shift position.

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.

Responsibilities:

• Work on routine assignments following established SOPS, Master Batch Record and cGMPs

• Collaborate with EHS and SMEs to identify potential hazards in manufacturing processes

• Creating and drafting detailed risk assessments for manufacturing processes.

• Evaluate potential risks, proposing mitigation strategies to ensure compliance with safety and regulatory standards

• Prepare, edit and maintain clear and accurate technical documentation related to manufacturing processes, safety protocols and risk assessments.

• Draft SOPs, work instructions and other technical documents

• Ensure all documentation is aligned with company standards and GMP guidelines

• Facilitate the approval process with relevant stakeholders and ensure all necessary reviews and approvals are obtained.

• Work closely with cross functional teams including manufacturing, EHS and SMEs to support process improvements and risk mitigation efforts

• Provide technical support for manufacturing operations, assisting with the implementation of new processes or improvements to existing processes

• Ensure consistency and precision in all risk assessments and related documentation

• Identify areas for improvement in manufacturing processes, risk assessments and documentation management

• Other duties as requested

Requirements:

• Three years’ relevant industrial experience in a cGMP manufacturing environment

• A relevant level 6 qualification is an advantage

• A safety related qualification or background is an advantage

• Excellent technical writing skills with the ability to present technical information clearly and concisely

• Strong attention to detail and ability to review documents for accuracy and consistency

• Knowledge of risk assessment methodologies and safety protocols in manufacturing environments

• Proficiency in document management

• Ability to work collaboratively in a cross functional team environment

• Strong organization and time management skills

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.