Title: Biologics Process Equipment Engineer
Location: Sligo, Ireland
Salary: €45 - €55 per hour
Type: 12-Month Contract
REF Code: DES-1032
Applicants must hold a valid EU passport or possess a visa that permits full-time work in Ireland.
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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