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Validation Specialist

  • COUNTRY: United States
  • CONTRACT: Unlimited contract

Group, Company and Organisation

COESIA is a group of innovation-based industrial solutions companies operating globally, headquartered in Bologna, Italy and fully owned by Isabella Seràgnoli. Coesia's companies are leaders in the sectors of: Advanced automated machinery and materials Industrial process solutions Precision gears Coesia’s customers are leading players in a broad range of industries, including Consumer Goods, Tobacco, Healthcare, Aerospace, Racing & Automotive and Electronics. Coesia companies ACMA - CERULEAN - CIMA - CITUSKALIX - EMMECI - FLEXLINK - G.D - GDM - GF - HAPA - IPI - MGS - MOLINS - NORDEN - R.A JONES - SACMO - SASIB - VOLPAK The Group has 92 operating units (55 of which with production facilities) in 31 countries, a turnover in 2013 of approx. 1,400 million Euro and over 6,000 employees.

Main Responsibilities / Activities

1. Produce project FATPs and assist Controls Designer with project FATP appendices 2. Backup Quality Support – may assist assembly team execute part or all of FAT validation procedures as required. 3. Implement validation standards as defined. 4. Assist with writing and editing material for work methods and procedures related to installation, operation, maintenance or training on specific machinery 5. Manages tasks of assigned projects to ensure on-time delivery of FATP documentation and testing

Key Competences / Leadership Attributes

1. Verify that functional specifications and deliverables are met prior to shipment 2. Understand GAMP5 requirements as they relate to MGS Machine Corporation 3. Standards-Maintain FATP and appendix templates with specific direction 4. PDF controls documentation for owner’s manuals 5. Typically works in office environment, but may spend some time in the warehouse environment with exposure to moving mechanical parts and moderate noise levels 6. Standard 40 hour week, but may vary depending on project requirements

Basic Requirements

1. Associates Degree in related field 2. 2+ years related work experience preferred 3. Demonstrated Technical writing experience 4. Quality background and knowledge of GAMP5 requirements 5. Logical, detail oriented and highly organized