Process Engineer

Headcount Solutions are seeking to recruit a Process Equipment Engineer for one of our leading multinational client sites in Sligo

Site/Location: Ballytivnan

Biologics Process Equipment Engineer

Responsibilities:

• To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
  
  
• Develop and modify procedures as needed to support the manufacturing operation.
  
  
• Participate in process, equipment, and facilities validations efforts and projects implementations.
  
  
• Process and equipment engineering Subject Matter Expert for a vial filling and isolator equipment from design phase to equipment handover.
  
  
• Review, and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s. Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site.
  
  
• Review vendor design documentation to ensure compliance with process and technical specifications.
  
  
• Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project.
  
  
• Support foller equipment installation integration and co-ordinate vendor supervision as required.
  
  
• Support the development of the project commissioning and validation plan.
  
  
• Review all process related validation protocols for completeness and accuracy.
  
  Requirements:
  
  
• A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
  
  
• At least six (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
  
  
• At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
  
  
• Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
  
  
• Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.
  
  EHS Responsibilities
  
  
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
  
  
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
  
  
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
  
  
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
  
  
• Attend all required EHS training and medical surveillance programs.
  
  
• Wear PPE as required.
  
  For further information please forward your CV