About Us
GerTEK is an engineering consultancy company specializing in project management, talent solutions and commissioning qualification and validation services.
Our Services
* Project Management: We partner with many of the world's largest life science & technology companies to deliver their most strategic and important projects.
* Talent Solutions: We have a technically strong personnel pool that ensures all important activities meet both current requirements and client needs.
Job Description
Title:
Project Engineer
Description:
We are seeking a highly skilled and motivated 'Project Engineer' with expertise in fill line systems to join our team. The ideal candidate will play a critical role in overseeing the design, installation, qualification, and maintenance of fill lines used in pharmaceutical manufacturing.
Major Duties and Responsibilities
1. Project Management: Lead projects related to fill line installation, upgrades, and validations, ensuring timely delivery and alignment with company objectives.
2. Fill Line Operations: Manage and optimize fill line equipment (e.g., aseptic filling, liquid vial filling, ampoules, syringes) to meet production and quality requirements.
3. Validation & Qualification: Develop and execute IQ, OQ, PQ protocols for fill lines, ensuring compliance with GMP and regulatory standards.
4. Troubleshooting: Diagnose and resolve technical issues related to fill line equipment and processes to minimize downtime.
5. Collaboration: Work closely with cross-functional teams, including Quality Assurance, Maintenance, and Production, to support smooth operations.
6. Vendor Coordination: Liaise with equipment manufacturers and service providers to ensure proper installation, maintenance, and upgrades of fill line systems.
7. Documentation: Prepare and maintain detailed project documentation, including engineering drawings, protocols, SOPs, and progress reports.
8. Compliance: Ensure all fill line operations and projects meet regulatory requirements (FDA, EMA, etc.) and internal quality standards.
9. 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.
About Working With Us
Opportunity to work on cutting-edge pharmaceutical projects.
Collaborative and supportive work environment.
Competitive compensation and benefits package.
Work Information
Job Type: Full-time
Work authorisation: Ireland (required)
Work Location: In person