Process Engineer

4 weeks ago

Sligo, Sligo, Ireland Headcount Solutions Full time

Headcount Solutions are seeking to recruit a Biologics Process Equipment Engineer for 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 project implementations.
  • Process and equipment engineering Subject Matter Expert for 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 vendors 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 designed, fabricated, and tested to meet the technical requirements of the project.
  • Support follower equipment installation integration and coordinate 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 five (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 within 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 the EHS system.
  • Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement in the EHS system.
  • Attend all required EHS training and medical surveillance programs.
  • Wear PPE as required.

For further information, please forward your CV.

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