Process Specialist
2 weeks ago
About No deviation At No deviation, we are dedicated to delivering patient‐centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally. Position Overview We are seeking a skilled and detail‐oriented Process Specialist with hands‐on experience in downstream processing for biologics or pharmaceuticals and a solid understanding of Manufacturing Execution Systems (MES). The ideal candidate will play a critical role in optimizing manufacturing processes, ensuring compliance with GMP standards, and bridging the gap between process engineering and digital manufacturing systems. Key Responsibilities Review the design, configuration, and logic of Master Batch Records (MBRs) and Parameter Value Lists (PVLs) to ensure they are fit for use in downstream processing environments. Act as the process subject matter expert (SME) for downstream operations during design workshops, collaborating with MES engineers, system integrators, and end users. Evaluate MES workflows to confirm alignment with actual shop floor operations, ensuring that critical process parameters, material flows, and equipment usage (e.g., chromatography skids, filtration units, bioreactors) are accurately captured. Participate in MBR design review sessions and provide feedback to ensure the proposed MES design supports safe, compliant, and efficient downstream manufacturing. Verify that equipment integration points (e.g., with OSI PI, DeltaV, recipe managers) are well‐defined and accurately represent intended interactions with the MES. Identify and elevate potential design risks, process mismatches, or GMP gaps in MES workflows. Support deviation resolution, change controls, and continuous improvement efforts related to MES design. Required Qualifications Bachelor's degree in Chemical Engineering, Biotechnology, Life Sciences, or related field. Strong hands‐on experience with downstream processing operations, including understanding of process steps, critical parameters, and typical plant operations. Prior involvement in MES implementation or system validation projects (e.g., PAS‐X, Siemens Opcenter) is highly preferred. Ability to independently assess MES design documents and provide process‐aligned feedback. Why join us?Generous Leave Policy. Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs. Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company. Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated. Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career. How to apply Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our teamPlease submit your resume, outlining your qualifications and experience relevant to the role, here. #J-18808-Ljbffr
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