SSi People’s Post

Validation is a job where few people have knowledge, skills and experience. It requires knowledge for Quality, Technical and Project Management for certain type of validation. Maybe that Validation person is just assigned to do Computer System alone, cleaning validation alone, test method alone, process validation alone or mixture of facility and utility. But there are just few people who knows every types of Validation with skills, knowledge and experience especially in highly regulated industries such as Pharmaceutical and Biotech. Validation people with such complete qualities are usually on Management Level and it is a stand alone Department to avoid conflict of interest due to the scope of its job which is checking/verifying processes established by Departments that are critical (direct or indirect impact) in manufacturing, testing and distribution. Therefore, Validation people and its Department is crucial and should be well established in a company.

Designing Pharma Manufacturing Facilities 🏭 A process engineer plays a pivotal role in designing pharmaceutical manufacturing facilities. It's not merely about laying out equipment and utilities; it's about crafting environments where safety, efficiency, and compliance seamlessly intertwine. Process engineers ensure that each stage of drug production meets stringent standards. This involves meticulous planning and validation of processes to prevent contamination and ensure product quality. Furthermore, they work closely with cross-functional teams to integrate cutting-edge technologies and innovative solutions, transforming conceptual plans into functional, compliant facilities. One notable aspect is the emphasis on sustainability. With increasing regulatory and environmental pressures, process engineers now must design systems that minimise waste and reduce energy consumption. This balance of technical expertise and environmental responsibility is shaping the future of pharmaceutical manufacturing. #PharmaceuticalEngineering #ProcessEngineering #SustainabilityInPharma

Join us in our vision to redefine the future of the workforce and industrial automation. . . . . #FANUC #FANUCEducation #integration #serialization #validation #planning #pharmaceutical #consulting #biotechnology #industrialrobotics #business #industrialautomation #consultingservices #roboticseducation #systemsintegration #projectmanagement #technology #URS #DDS #CS #software #packaging #computersystems #engineering #VanguardVision

Working as Validation Manager in Pharmaceutical, Biotech, and Medical Devices is not an easy job. You need to be an expert in Business Analysis to understand the requirements of the project or the organization, you need to be an expert in Quality Assurance to align with QMS, policies, and standards, and lastly and you need to be an expert in Technical matters. For all of this expertise, one key element to become successful is COLLABORATION. Through collaboration, you can be able to find out solutions, and better understand the project, problem, and subject. #BusinessAnalysis #Validation #QualityAssurance #TechnicalSupportAnalysis #ProjectManagement #JobSeeker

Prepare for a future loaded with innovation and achievements. We can help you become FANUC America Corporation certified. . . . . #FANUC #FANUCEducation #integration #serialization #validation #planning #pharmaceutical #consulting #biotechnology #industrialrobotics #business #industrialautomation #consultingservices #roboticseducation #systemsintegration #projectmanagement #technology #URS #DDS #CS #software #packaging #computersystems #engineering #VanguardVision

🔬 Excited to delve into the interconnected world of #TechnologyTransfer, #ProcessEngineering, #ContinuousManufacturing, and #PATTechnology in the Manufacturing Industry! 💊 As a process engineer, I've witnessed firsthand how these verticals are intricately linked, forming the backbone of efficient pharmaceutical manufacturing processes. Technology transfer is the bridge that connects research and development with production, ensuring seamless transitions and maintaining product integrity throughout the lifecycle. Process engineers play a crucial role in this transfer, optimizing procedures to ensure scalability and reproducibility. Continuous manufacturing takes this a step further, offering real-time insights into production processes. By integrating PAT technology, manufacturers can monitor critical parameters in real-time, enabling proactive adjustments to maintain product quality and consistency. This interconnected approach not only enhances efficiency but also facilitates rapid innovation and adaptation to changing market demands. Let's continue pushing the boundaries of what's possible in pharmaceutical manufacturing through collaboration and leveraging the synergies between these vital verticals! 💡 #innovation #operationalexcellence #TechTransformation #EngineeringExcellence

Ever wondered what it takes to be a PBE Expert SME? 🕵️♂️ ⚙️ Process Engineering: Skilled in URS, P&ID, Layout, HVAC, Cell Gene, OEL, BSL, XP, Risk Analysis, RTM, and DQ, our Process Engineers ensure optimal system design and regulatory compliance. 🏆 +30 Years of Experience: With decades of experience, PBE Experts provide comprehensive services in Full GMP, Life Sciences, Pharmaceutical, Biotech, Vaccine, Cell Gene, Green Energy, Cannabis, Food, AI, and Industry 4.0. ✅ Validation & CSV: Our specialists excel in VMP, CQV (IQ, OQ, PQ), CSV, IT Validation, Cleaning Validation, and Process Validation, ensuring your systems meet all regulatory standards. 🌍 +300 Project Success: PBE Experts have successfully completed over 300 projects across North America, Europe, Africa, Asia, and the Middle East, achieving compliance with FDA, EMA, and Health Canada regulations. 📋 Quality Assurance: Dedicated to SOP Batch Release, Investigation, RCA & CAPA, Calibration, GMP Audit & PAI, our Quality Assurance team ensures excellence in every project. 💼 Project Management: Our Project Managers oversee Delivery, Installation, FAT, SAT, On-Site Works Management, Product Rework, and New Drug Development, ensuring project success from start to finish. ➡️Unlock the secrets of GMP excellence with PBE Expert. 🌐Learn more at www.pbe-expert.com. #GMP #LifeSciences #Pharmaceutical #Biotechnology #Validation #Quality #Management #Expertise #Compliance #Innovation #Health #Engineering #Success #PBEExpert #Biotech #Pharma #QA #Production #Industry #Research #Development #Technology #Laboratory #Safety #Audit #Training #Project #System #Process #Improvement #Optimization #Standards #Certification #Sciences #Pharmaceutique #Qualité #Gestion #Conformité #Santé #Ingénierie #Succès #AQ #Sécurité #Formation #Processus #Amélioration #Normes #Laboratoire #Développement #Technologie #Industrie #Recherche #MedTech #BioPharma #LifeScience #DrugDevelopment #ClinicalTrials #RegulatoryAffairs #MedicalDevices #Cleanroom #GoodManufacturingPractice #ProcessValidation #ComplianceAudit #PharmaEngineering #PharmaQuality #BioManufacturing #Chemistry #PharmaceuticalEngineering #PharmaceuticalScience

What does Business Platforms mean when we say "be a part of an expert team of MES Engineers"? Here's what... 1️⃣ 𝘊𝘰𝘯𝘵𝘪𝘯𝘶𝘰𝘶𝘴 𝘓𝘦𝘢𝘳𝘯𝘪𝘯𝘨: You will work alongside industry veterans, learning the latest MES technologies and best practices to stay at the forefront of the industry. 2️⃣ 𝘊𝘰𝘭𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘪𝘷𝘦 𝘌𝘯𝘷𝘪𝘳𝘰𝘯𝘮𝘦𝘯𝘵: Our culture thrives on teamwork. We share knowledge, ideas, and challenges to create solutions that drive our clients' success. 3️⃣ 𝘐𝘮𝘱𝘢𝘤𝘵𝘧𝘶𝘭 𝘞𝘰𝘳𝘬: Your contributions will directly impact the efficiency, quality, and productivity of leading manufacturing operations worldwide. 4️⃣ 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯: We don't just follow trends; we set them. Our engineers are encouraged to push boundaries and think outside the box to deliver cutting-edge solutions. At Business Platforms, being part of our MES team isn't just a job - it's an opportunity to grow, transform, and make a difference. #MES #ManufacturingExecutionSystems #Culture #Pharma #Pharmaceutical

Does your manufacturing facility require extra support within your engineering department? are you experiencing a busy period? or short staffed due to annual leave? maybe it's something I can assist with? I have worked in a fast paced, high volume, world leading pharmaceutical manufacturer for over 20 years within the Maintenance Department covering all aspects of reactive/proactive maintenance, tpm, installation and decommission projects. [email protected] [email protected] #mechanicalengineering #engineeringexcellence #maintenanceengineer #maintenanceandrepair #manufacturing #engineeringservices

📚 Ensuring Quality and #Compliance in Process Validation 💎 #History 🌲 Process Validation has been a legal #requirement since 1963, emphasizing the importance of quality assurance and preventing injuries or deaths caused by substandard products. 🌲 It was a crucial step forward in ensuring the #safety and efficacy of pharmaceuticals. 🌲 This requirement led to a shift from reactive measures to #proactive quality control. 🔐⚖️ 💎 #Principle 🌲 Process Validation is the cornerstone of manufacturing excellence. It ensures that our processes, within their specified design #parameters, consistently produce high-quality finished products. 🌲 By providing documentary #evidence, we gain the confidence that our products meet the required quality standards consistently. 💎 #Approaches 🌲 Process Validation can be approached through three #methods: ▶Prospective ▶Concurrent ▶Retrospective Validation. 🌲 Prospective Validation involves documenting and evaluating the process #before actual production. 🌲 Concurrent Validation assesses the process #during production. 🌲 Retrospective Validation analyzes #historical data to validate existing products. 🌲 Each approach has its own merits and #suitability depending on the situation. 💎 Content of #Validation 🌲 The typical content of a validation #report includes ▶Safety instructions ▶Process flow charts ▶Critical process #parameters ▶Product testing ▶Cleaning validation 🌲 These elements provide a comprehensive overview of the manufacturing process and its compliance with #regulatory requirements. 💎 #Challenges 🌲 These challenges encompass the facility, environment, equipment, personnel, and #adherence to standard procedures. 🌲 By addressing these challenges head-on, we can establish robust validation processes that guarantee #consistent quality and compliance. 👉 Follow Henry and Pharma Broadcast for more updates _________________________________________________ 🌟 Process Validation is not just a regulatory requirement; it is a #critical step in ensuring the production of high-quality pharmaceutical products. #ProcessValidation #QualityAssurance #Compliance #ManufacturingExcellence #PharmaceuticalIndustry #ProductSafety #RegulatoryCompliance