Title: Process (Bioprocess or GMP) Equipment Engineer / Validation Engineer (Biologics)
Location: Sligo, Ireland
Salary: DOE
Type: Contract
REF Code: DES-1032
Overview
Our client is looking for a Biologics Process Equipment Engineer to become part of their engineering team. The role involves supporting pharmaceutical operations while adhering to safety, regulatory, and organizational guidelines. The selected individual will be instrumental in equipment, facility, and process validation activities as well as project execution.
The ideal candidate needs to have a valid visa/citizenship to work in Ireland/Europe.
Key Responsibilities:
* Assist with engineering duties in pharmaceutical operations, ensuring alignment with safety and regulatory standards.
* Create and revise procedures to enhance manufacturing processes.
* Act as the Subject Matter Expert (SME) for vial filling and isolator systems, from initial design through to equipment turnover.
* Evaluate and provide approval for PFDs, specifications, layouts, and P&IDs.
* Coordinate between vendors and on-site teams to ensure proper equipment integration.
* Manage FAT and SAT processes to confirm equipment meets defined technical specifications.
* Supervise equipment setup, integration, and vendor activities.
* Prepare and carry out commissioning and validation procedures following Good Engineering Practice (GEP).
* Review and implement validation protocols to meet project deadlines.
* Ensure equipment and processes are designed with reliability before installation.
* Lead manufacturing and validation phases throughout the course of the project.
* Facilitate technical transfers related to new product launches at the site.
* Analyse process deviations and equipment issues in collaboration with operations, quality, and science departments.
* Promote continuous process and equipment improvements.
* Maintain compliance with cGMP standards, ISO/FDA regulations, and internal policies.
* Oversee external contractors when necessary.
Qualifications & Experience:
* A Bachelor’s or Master’s degree in Engineering, Science, or a related technical field.
* At least 5 years of experience in process equipment or manufacturing engineering within the pharmaceutical or healthcare sectors.
* A minimum of 3 years working in biotechnology, pharmaceutical, or healthcare manufacturing settings.
* Familiarity with biotechnological drug production, sterile drug processing, solution formulation, and sterilization is advantageous.
* Experience in launching new products in pharmaceutical environments is a plus.
* Strong analytical abilities with capacity to assess alternatives and apply creative solutions.
* Keen attention to detail with a focus on getting it right the first time.
* Strong communication skills, both verbal and written.
* Demonstrated leadership, collaboration, and interpersonal skills.
* Capable of working independently and making sound technical judgments.
Contact Information:
To discuss this role in more detail, contact Jesse at +353 94 931 6005 or jp@dillones.ie for a confidential discussion.
#J-18808-Ljbffr