
Digital Manufacturing Specialist
2 weeks ago
We are seeking experienced professionals with expertise in digital manufacturing, computer system validation, and software applications. As a Senior/Consultant, you will support our clients through the entire project lifecycle, ensuring all computer systems and software applications are validated according to industry standards, regulatory, and client requirements.
The ideal candidate will have a strong understanding of validation methodology, including IQ, OQ, PQ, and regulatory knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations. You will also have experience in technical proficiency, including troubleshooting and maintaining validated systems. Additionally, you should have a good understanding of manufacturing execution systems (MES), such as Emerson Syncade, Körber/Werum PAS-X, Siemens Opcenter Execution Pharma, POMSnet, Rockwell PharmaSuite, and data management or integration technologies like OSI PI.
To be considered for this role, you should have at least 3 years of experience in a pharmaceutical or GMP environment, with expertise in either GxP Computer Systems Validation, MES, or data management/integration technologies. A bachelor's degree in engineering or science is also required. Fresh graduates may be considered for junior roles if they have internship experience in the pharmaceutical industry.
We offer impactful projects with international healthcare clients, a professional work environment, leadership opportunities, career development, and structured training programs. If you're ready to make a significant impact in the life sciences field and advance your career with a rapidly growing firm, we invite you to apply for this exciting opportunity.
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