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Reporting to the department lead, this role is primarily responsible for the production of products that meet or exceed pre-determined specifications. Responsibilities include manufacture, inspection, packaging, labelling, and documentation to ensure quality, production, and traceability in accordance with Quality and Environmental Management Systems.
Essential Duties and Responsibilities:
1. Manage production flow and output, including tracking product at each stage, proper labelling, and inventory management using Kanbans and automated MES and PLC systems, to ensure optimal equipment uptime and target outputs.
2. Operate equipment such as washers, autoclaves, envision systems, tooling, packaging, mixing, drop mills, feed mills, calendars, winders, rotocure, and slitters.
3. Follow standard operating procedures for PPE and gowning requirements for entry into production, quality, labs, and cleanroom areas.
4. Prepare, set up, and clean machines as required, maintaining housekeeping and materials management policies, with a focus on continuous process improvement using Lean principles.
5. Perform cleanroom cleaning as per protocols.
6. Collect, record, and label samples for testing by QA and Lab departments, ensuring proper documentation.
7. Conduct product testing and record results accurately.
8. Maintain process equipment, assist with preventive maintenance, troubleshooting, and repairs within qualification scope.
9. Contribute to writing, revising, and implementing operational procedures and training materials, ensuring compliance.
10. Support continuous improvement initiatives, investigations, change controls, Kaizen events, root cause analysis, and tools like FMEA and A3/A4.
11. Comply with global policies, procedures, guidelines, regulatory requirements, and cGMP standards.
12. Understand departmental responsibilities and support business process understanding.
13. Promote a safe and compliant culture, adhering to environmental, health, and safety regulations.
14. Follow methods, procedures, and policies aligned with Quality and Environmental Management Systems.
15. Act in accordance with company guiding principles and code of conduct.
16. Perform other duties as assigned.
Education:
* Apprenticeship, certificate, or diploma preferred, ideally in mechanical or manufacturing disciplines.
* Minimum education: Leaving Certificate.
Work Experience:
* Typically 1-3 years of experience in bio-pharmaceutical, pharmaceutical, medical device industries, or GMP environments.
Preferred Knowledge, Skills, and Abilities:
* Knowledge of cGMP standards advantageous.
* Proficiency in Microsoft Office and related applications.
* Support Lean Sigma initiatives.
* Ability to interpret safety rules, operating instructions, and process specifications.
* Willingness to work in a controlled cleanroom environment with PPE.
* Awareness of SOPs related to the role.
* Self-motivated, flexible, with excellent time management, attention to detail, mechanical aptitude, and communication skills.
* Proven team player with organizational skills.
Travel Requirements:
Up to 13 business days per year (5%).
Job Summary:
Responsible for producing products that meet specifications, including manufacturing, inspection, packaging, labelling, and documentation, in compliance with quality and environmental systems.
Additional Notes:
Supports diversity and equality, fostering a respectful environment. Employment contingent upon background and drug screening where permitted by law.
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