Manufacturing Equipment Specialist

3 days ago

Sligo, Sligo, Ireland beBeeProcess Full time €90,000 - €120,000

Job Title:

Process Equipment Specialist.

    We are seeking a highly motivated engineer to join our operations team, responsible for supporting the design, commissioning and validation of manufacturing equipment, ensuring alignment with safety, quality and regulatory standards.

    Key Responsibilities:

  • Act as subject matter expert for vial filling and isolator systems from design to validation.
  • Review and approve PFDs, P&IDs, layouts and specifications.
  • Lead FAT/SAT activities and oversee vendor interactions to ensure compliance with site and regulatory requirements.
  • Support equipment integration, installation, commissioning and validation.
  • Develop and update procedures to align with manufacturing and regulatory needs.
  • Troubleshoot equipment issues, investigate process deviations and coordinate technical resolutions.
  • Ensure ongoing equipment performance, process optimization and adherence to maintenance strategies.
  • Develop commissioning and validation strategies following Good Engineering Practice (GEP).
  • Review and execute validation protocols ensuring alignment with project timelines.
  • Ensure readiness for audits and inspections by upholding cGMP, ISO and FDA standards.
  • Work closely with cross-functional teams to support equipment lifecycle.
  • Mentor and provide guidance to peers and contractors; lead training where applicable.
  • Drive continuous improvement and support cost-saving initiatives and new technology integration.

    Required Skills and Qualifications:

  • Bachelor's or Master's degree in Engineering, Science or a related technical discipline.
  • Minimum 5 years of experience in equipment or process engineering within the pharmaceutical or biotech sector.
  • At least 3 years' experience in GMP manufacturing environments.
  • Knowledge of parenteral drug manufacturing, sterilisation and aseptic processing is highly desirable.
  • Experience with new product introduction and tech transfer is advantageous.

    Addition Expectations:

  • Support EHS policies, actively report incidents or unsafe conditions and contribute to a safe working environment.
  • We wear appropriate PPE and attend all required safety and compliance training.
  • May supervise contractors or lead cross-functional project teams.
  • Will have external contact with vendors, engineers and auditors.

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