▷ Apply Now: Project Engineer- Fill Lines

2 weeks ago

Sligo, Ireland Gertek Project Management Full time

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: Title: Project Engineer We are seeking a highly skilled and motivated 'Project Engineer' with expertise in fill line systems to join our team at Sligo . The ideal candidate will play a critical role in overseeing the design, installation, qualification, and maintenance of fill lines used in pharmaceutical manufacturing. This individual will ensure all projects are executed efficiently, adhering to GMP regulations, quality standards, and project timelines. Major Duties and Responsibilities Project Management: Lead projects related to fill line installation, upgrades, and validations, ensuring timely delivery and alignment with company objectives. Fill Line Operations: Manage and optimize fill line equipment (e.g., aseptic filling, liquid vial filling, ampoules, syringes) to meet production and quality requirements. Validation & Qualification: Develop and execute IQ, OQ, PQ protocols for fill lines, ensuring compliance with GMP and regulatory standards. Troubleshooting: Diagnose and resolve technical issues related to fill line equipment and processes to minimize downtime. Collaboration: Work closely with cross-functional teams, including Quality Assurance, Maintenance, and Production, to support smooth operations. Vendor Coordination: Liaise with equipment manufacturers and service providers to ensure proper installation, maintenance, and upgrades of fill line systems. Documentation: Prepare and maintain detailed project documentation, including engineering drawings, protocols, SOPs, and progress reports. Compliance: Ensure all fill line operations and projects meet regulatory requirements (FDA, EMA, etc.) and internal quality standards. Continuous Improvement: Identify and implement process improvements to enhance productivity, quality, and efficiency in fill line operations. Qualifications & Requirements Education: Bachelor's degree in Engineering (Mechanical, Electrical, Process, or related field). Experience: Minimum 3-5 years of experience as a Project Engineer in the pharmaceutical or biopharmaceutical industry. Proven expertise in fill line operations, validation, and maintenance. Technical Skills: Strong knowledge of GMP, FDA, EMA regulations, and cleanroom standards. Familiarity with fill line equipment from leading manufacturers (e.g., Bosch, Optima, IMA, or similar). Experience with PLCs, automation, and SCADA systems is a plus. Proficient in AutoCAD or similar software for reviewing technical drawings. Soft Skills: Excellent problem-solving and analytical skills. Strong communication and collaboration abilities. Project management expertise with the ability to handle multiple priorities. Preferred Certifications Lean Six Sigma or equivalent. Project Management Professional (PMP) certification. ISO 13485 or similar quality management certifications. Why Join Us? Opportunity to work on cutting-edge pharmaceutical projects. Collaborative and supportive work environment. Competitive compensation and benefits package. Job Type: Full-time Work authorisation: Ireland (required) Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.

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