Process Equipment Engineer

4 weeks ago

Galway, Galway, Ireland Dillon Engineering Services Full time

Title: Process Equipment Engineer

Location: Sligo, Ireland

Salary: €45 - €55 per hour

Type: 12-Month Contract

REF Code: DES-1032

Overview

We are seeking a Biologics Process Equipment Engineer to join our clients engineering team. This role supports pharmaceutical operations while ensuring compliance with safety, regulatory, and organisational standards. The successful candidate will play a key role in process, equipment, and facility validation efforts and project implementations.

Key Responsibilities:

  • Support engineering functions in pharmaceutical operations, ensuring compliance with safety and regulatory requirements.
  • Develop and modify procedures to optimise manufacturing operations.
  • Serve as a Subject Matter Expert (SME) for vial filling and isolator equipment, from the design phase to equipment handover.
  • Review and approve Process Flow Diagrams (PFDs), specifications, layouts, and Piping & Instrumentation Diagrams (P&IDs).
  • Act as a liaison between vendors and site teams to ensure seamless equipment integration.
  • Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to verify that equipment meets technical requirements.
  • Oversee equipment installation, integration, and vendor supervision.
  • Develop and implement commissioning and validation plans in accordance with Good Engineering Practice (GEP).
  • Review and execute validation protocols to align with project timelines.
  • Ensure reliability by design in equipment and processes prior to installation.
  • Lead manufacturing and validation activities throughout the project lifecycle.
  • Support technical transfers for new product introductions to the site.
  • Investigate process exceptions and equipment malfunctions, collaborating with operations, quality, and scientific teams.
  • Drive continuous improvement initiatives for process and equipment upgrades.
  • Ensure compliance with cGMP, ISO/FDA regulations, and company policies.
  • Supervise external contractors as required.

Qualifications & Experience:

  • Bachelor's or Master's degree in Engineering, Science, or a related technical discipline.
  • 5+ years of experience in process equipment, or manufacturing engineering within the pharmaceutical or healthcare industry.
  • 3+ years of experience in a biotechnology, pharmaceutical, or healthcare manufacturing environment.
  • Knowledge of biotechnological drug manufacturing, parenteral drug processing, solution preparation, and sterilization operations is preferred.
  • Experience with new product introductions in pharmaceutical facilities is desirable.
  • Strong problem-solving skills with the ability to evaluate multiple solutions and implement innovative approaches.
  • High attention to detail with a Right First Time mindset.
  • Excellent verbal and written communication skills.
  • Strong leadership, interpersonal, and teamwork capabilities.
  • Ability to operate autonomously and make informed technical decisions.

To discuss this role in more detail contact Corné at 094 9316002 or corne@dillones.ie for a confidential discussion.

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