Pharmaceutical Equipment Specialist

2 days ago

Sligo, Sligo, Ireland beBeeProcess Full time €92,200 - €113,200
Biologics Equipment Specialist Role

We seek a highly skilled Biologics Equipment Specialist to support our manufacturing operations. This position requires expertise in the design, commissioning, validation, and lifecycle management of equipment for pharmaceutical and biotech production.


Main Responsibilities:
  • Lead the development of technical requirements for vial filling and isolator systems.
  • Review and approve engineering designs, layouts, and specifications.
  • Collaborate with vendors to ensure compliance with site and regulatory standards during FAT/SAT activities.
  • Support equipment installation, commissioning, and validation.

Operational Support:
  • Develop and maintain procedures aligned with manufacturing needs and regulatory requirements.
  • Troubleshoot equipment issues, investigate process deviations, and coordinate technical resolutions.
  • Ensure ongoing equipment performance, process optimization, and adherence to maintenance strategies.

Validation & Compliance:
  • Develop commissioning and validation strategies adhering to Good Engineering Practice (GEP).
  • Review and execute validation protocols ensuring alignment with project timelines.
  • Maintain readiness for audits and inspections by upholding cGMP, ISO, and FDA standards.

Collaboration & Leadership:
  • Work closely with cross-functional teams (Operations, Quality, S&T) to support equipment lifecycle.
  • Mentor and guide peers and contractors; lead training where applicable.
  • Promote continuous improvement and support cost-saving initiatives and new technology integration.

Qualifications:
  • Bachelor's or Master's degree in Engineering, Science, or a related technical discipline.
  • A minimum of 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.

Key Skills and Competencies:
  • Strong problem-solving ability under pressure.
  • Detailed focus on compliance and operational excellence.
  • Excellent verbal and written communication skills.
  • Strong interpersonal and stakeholder management capabilities.
  • Ability to work independently and make informed technical decisions.
  • High level of integrity and commitment to quality.
  • Familiarity with automation/control systems and their impact on processes.

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