Validation Engineer – Pharma Packaging Equipment
Company: Capmatic Europa
- Location: County Dublin, Ireland
- Seniority: Entry level
- Employment type: Full-time
- Posted: 6 days ago
- Offer language: English
Job description
About Capmatic
Capmatic is an exceptional organization that has been delivering outstanding packaging solutions for more than 62 years. Since 1964, Capmatic has been a trusted leader in the industry, renowned for its expertise in designing and manufacturing custom Monoblock systems and automated equipment across diverse sectors.
Our team of professionals excels in filling, counting, capping, labeling, and robotics to bring unique packaging visions to life. Capmatic’s passion and dedication make us the go-to choice for comprehensive packaging solutions. With well over 5,000 installations worldwide, our proven reliability and commitment to excellence continue to fuel our international growth.
Role Overview
We are seeking a detail-oriented and results-driven Validation Engineer specializing in Pharmaceutical Packaging Equipment. In this role, you will be responsible for leading, managing, and executing validation activities for new and existing equipment, supporting systems, and computer/software validation in compliance with global regulations and customer URS requirements.
Key Responsibilities
- Validation Documentation: Create, manage, and execute all required validation documentation for new equipment, supporting systems, and system updates.
- Computer Systems Validation (CSV): Apply thorough working knowledge of GAMP classification to properly classify hardware/software and provide guidance on CSV activities.
- Protocol & Deviation Management: Oversee protocol amendments, resolve discrepancies/deviations, and ensure proper documentation and corrective actions.
- Document Approvals: Ensure timely approval of critical validation deliverables, including FDS, DQ, HDS, SDS, FAT, and IQ/OQ protocols.
- Risk Assessment: Apply appropriate risk assessment tools to determine risk levels and ensure full compliance with URS (User Requirement Specifications).
- Regulatory Guidance: Provide interpretation and guidance on European regulations, cGMP, and internal corporate/site procedures.
- Project Delivery: Control the validation package and manage timelines to ensure validation efforts do not negatively impact business deadlines.
Qualifications & Experience
- Education: 3rd level qualification (Bachelor's degree or equivalent) in Engineering, Science, or a related technical field.
- Experience: Minimum 3 years of hands-on experience in an FDA-regulated or cGMP environment.
- Regulatory Knowledge: Strong working knowledge of European regulations, GMP/cGMP guidelines, and GAMP standards.
- Domain Expertise: Experience with pharmaceutical or medical product manufacturing, with a focus on automated processes and filling/packaging operations.
- Key Skills: Computer Systems/Software Validation (CSV), protocol drafting, risk assessment, and cross-functional communication.
Working Conditions & Travel
- Primary Location: Dublin, Ireland
- Travel Requirements: Occasional travel across Europe and to Capmatic Headquarters in Canada for training and site deployment.
