Headcount Solutionsare seeking to recruit aBiologics Process Equipment Engineerfor one of our multinational clients sites in Sligo 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&IDs.
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.
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.
Ownership/Accountability This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
The position has a high level of autonomy and individuals are expected to work on their own initiative.
Demonstrates an ethos of Right First Time at all times.
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures and guidelines.
Shows a high level of tenacity to ensure closure of issues.
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 Skills: Commissioning Documentation Biopharmaceutical