Job Summary:
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The Process Engineer will support the development and implementation of pre-filled syringe processes within a sterile manufacturing environment. This role focuses on continuous improvement, technology transfer, and capacity enablers for monoclonal antibody (mAb) commercial products.
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Responsibilities:
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1. Act as Process Engineer for projects related to pre-filled syringe operations
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2. Develop and execute filter tests, fill weight cycles, and cleaning verification activities
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3. Generate and execute documentation such as recipe documents, FMEAs, protocols, and reports
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4. Lead investigations and manage change controls to resolve technical issues
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5. Ensure activities are delivered on schedule and with optimal results
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6. Support daily operations in the syringe filling area and implement corrective actions for continuous improvement
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7. Collaborate with material/component vendors during projects
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8. Write Process/Operational Control Strategy documents and support operator training
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9. Create hour-by-hour schedules for planning line time and execution of deliverables
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10. Provide technical support to implement process improvements and new product transfers
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11. Participate in GMP regulatory and safety audits
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* Requirements:
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12. Honours degree in an Engineering discipline
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13. 3+ years of relevant experience in a highly regulated GMP environment
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14. Experience in sterile manufacturing operations is an advantage
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15. Experience with syringe filling processes is a distinct advantage
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16. Experience in new product introduction is preferred
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17. Strong problem-solving skills
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* About Us:
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At {company}, we strive to provide a work environment that fosters innovation, collaboration, and growth. We believe in hiring talented individuals who share our commitment to excellence and customer satisfaction.
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What We Offer:
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A dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.
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How to Apply:
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Apply online by submitting your resume and cover letter. We thank all applicants for their interest; however, only those selected for an interview will be contacted.