Ward Automation’s Post

Hello friends, I have an opening for job Manufacturing Engineer – North Haven, CT. Kindly reach me at #908-615-1717 or #email your #resume at #[email protected]. Job Title: Manufacturing Engineer Job Location: North Haven, CT Job Type: Full Time/Contract   Job Description: Perform equipment validation. Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Need to conduct qualification, verification, and validation activities to produce medical devices. Work with CFT teams in troubleshooting problems on the production floor. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements. Drive the execution of various validation and PFMEA activities as per the project plan Execute Site acceptance test and Factory acceptance test based on North Haven Execute Validation Gap analysis of various product families based in Medtronic Plan and initiate CDPs associated with the various validation activities Co-ordination with stakeholders Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Should be experienced in conducting Time Study for various assembly line Should be experienced in Medical device manufacturing assembly lines Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices. Need to conduct qualification, verification, and validation activities to produce medical devices. Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation. Need to design, procure, and fabricate tooling and fixtures. Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices. Train, develop, and/or provide work direction to operators and technicians. Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions. Participate in design control efforts related to risk analysis (failure mode and effect analysis) & design reviews. Work with CFT teams in troubleshooting problems on the production floor. Need to identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.  

Process validation .

🔍 **Navigating the Landscape: Verification vs. Validation in Quality Control ⚙️** In the realm of Quality Control (QC), understanding the nuances between Verification and Validation is pivotal. Let's unravel these concepts and explore their impact on ensuring top-notch product quality. 🔗 **Verification: Ensuring Precision in the Process** Verification is the process of confirming that a system or component meets specified requirements. It's the meticulous check to ensure that each step of the process adheres to the predefined standards. In QC, verification involves confirming that the equipment, processes, and procedures are in line with the established criteria. ✨ **Key Focus Areas:** - Equipment Calibration - Process Adherence - Document Compliance - Procedural Checks 🧰 **Verification in Action:** Consider verifying a weighing scale in a pharmaceutical setting. It involves confirming that the scale displays accurate measurements, ensuring the foundation for quality production. 🔍 **Validation: Ensuring Consistency in Product Performance** Validation goes a step further. It is the systematic, comprehensive evaluation of a process to ensure it consistently produces a product meeting predetermined specifications. In QC, validation validates not just the components but the entire process, affirming it's capable of delivering products with consistent quality. ✨ **Key Focus Areas:** - Process Capability - Consistency Across Batches - Statistical Analysis - Product Performance 🧰 **Validation in Action:** Imagine validating an assembly line for electronic devices. It's not just about confirming each component's accuracy; it's about ensuring that every unit produced meets performance standards consistently. 🤝 **Their Synergistic Dance in QC:** Verification and Validation are not mutually exclusive; rather, they complement each other in QC. Verification sets the stage by confirming adherence to standards, while Validation ensures the entire process is not just compliant but consistently reliable. Together, they fortify QC practices, leaving little room for errors. 💬 **Join the Conversation:** How do you see Verification and Validation influencing QC in your industry? Share your insights and experiences in the comments below! #QualityControl #Verification #Validation #QualityAssurance #ManufacturingExcellence #LinkedInDiscussion

Stage 1 of Process Validation - Process Design Process design defines the commercial manufacturing operation and sets the foundation for successful production. The main goal of this stage is to identify and establish a reliable and efficient process for manufacturing a product. This stage involves conducting early experiments, adhering to good documentation practices, and testing and retesting the processes for consistent optimal outcomes. Additionally, process controls are put into place to monitor and maintain the quality of the product throughout production. Elevate your commissioning, qualification, and validation processes with our team of skilled life science professionals. #validation #CAVESoultions #CAVEApproach

I'm #hiring for #validationengineer #validation #qualityengineer #injectionmolding #injectionmold #ISO13485 #smallcomponent #remoteopportunity #medicaldeviceindustry #medicaldevice #medicaldevices

Special process auditing refers to an examination and evaluation of specific processes or systems within an organization to ensure they meet certain standards, regulations, or requirements. This type of auditing focuses on critical processes that have a significant impact on product quality, safety, or compliance. Special process audits are often performed in industries such as: 1. Aerospace 2. Automotive 3. Medical devices 4. Pharmaceuticals 5. Food processing Examples of special processes that may be audited include: 1. Welding 2. Heat treatment 3. Painting or coating 4. Cleaning and sanitizing 5. Sterilization 6. Calibration 7. Testing and inspection The purpose of special process auditing is to verify that these critical processes are: 1. Effectively controlled 2. Consistently applied 3. Compliant with relevant standards or regulations 4. Documented and recorded 5. Monitored and improved By conducting special process audits, organizations can ensure the quality and reliability of their products or services, reduce risks, and maintain compliance with industry requirements.

#hiring *Validation Maintenance Manager (Hybrid)*, Boston, *United States*, $171K, fulltime #jobs #jobseekers #careers $171K #Bostonjobs #Massachusettsjobs #TradesServices *Apply*: https://lnkd.in/g-89RU7D By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Job Title: Validation Maintenance Manager Location: Lexington, MA About the role: As the Validation Maintenance Manager, you will provide leadership to the Validation Maintenance Program for annual requalification of GxP manufacturing equipment used for commercial production, including developing validation strategy to the site and global projects. You will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification / validation, and final report documents. You will report to the Engineering Services Lead. How you will contribute: Assess, qualify and validate equipment, critical systems (utilities), facilities, computerized systems, cleaning and sterilization processes. Coordinate with manufacturing and production schedules to access equipment to perform requalification on performance, cleaning or periodic reviews. Improve and adapt the Validation Maintenance Program processes to meet demands in the manufacturing facility by building partnerships across departments. Lead and represent the respective validation elements to determine validation strategy and system validation requirements based on concepts of life cycle to meet regulatory guidelines and industry standards. Develop protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans consisting of both initial validation efforts and revalidation. Write protocols and reports, and interpret validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1). Plan, and schedule validation assignments and lead the validation team to prepare protocols and material for each activity. Guide peers in Validation and Engineering Departments to use statistically based Quality Engineering approaches in project, test plans and in analysis of test results. Review change control requests with potential impact to validated state of validation elements, as applicable. Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identify gaps related to validation requirements and Glo

#hiring *Senior Director, Engineering (DDC)*, Philadelphia, *United States*, fulltime #jobs #jobseekers #careers #Philadelphiajobs #Pennsylvaniajobs #Engineering *Apply*: https://lnkd.in/gw5zG_77 Director, Engineering (Drug-Device Combo Products) page is loaded Director, Engineering (Drug-Device Combo Products) Apply locations Philadelphia, PA, USA time type Full time posted on Posted Yesterday job requisition id JR106535 Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The main responsibilities of the Director, Engineering for drug-device combination products are focused on the planning and execution of projects from estimating to launch: Manage and communicate the site portfolio of drug-device combination product NPI projects, ensuring projects are managed to intended capital and resource cost and scope Provide resources and oversight to project estimating activities to develop a trusted project resource plan Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams. Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost Leading change and continuous improvement activities for the drug-device combination products NPI process Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost Target Achievement Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Oversees NPI engineering project management for drug-device combination products.Supervises a staff of engineers and/or engineering technicians.Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by s

#hiring *Director, Engineering (Drug-Device Combo Products)*, Philadelphia, *United States*, fulltime #jobs #jobseekers #careers #Philadelphiajobs #Pennsylvaniajobs #Engineering *Apply*: https://lnkd.in/gMcMXnqB Director, Engineering (Drug-Device Combo Products) page is loaded Director, Engineering (Drug-Device Combo Products) Apply locations Philadelphia, PA, USA time type Full time posted on Posted Yesterday job requisition id JR106535 Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The main responsibilities of the Director, Engineering for drug-device combination products are focused on the planning and execution of projects from estimating to launch: Manage and communicate the site portfolio of drug-device combination product NPI projects, ensuring projects are managed to intended capital and resource cost and scope Provide resources and oversight to project estimating activities to develop a trusted project resource plan Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams. Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost Leading change and continuous improvement activities for the drug-device combination products NPI process Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost Target Achievement Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Oversees NPI engineering project management for drug-device combination products.Supervises a staff of engineers and/or engineering technicians.Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive

If you are a Production Manager for a medical device manufacturer you are intimately familiar with the challenges of executing and maintaining IQ (Installation Qualification) and OQ (Operation Qualification). Manufacturing processes can consist of multiple steps involving several pieces of equipment and ensuring all equipment fulfills all predetermined functionality and safety requirements, as well as regulatory standards. If you are lucky enough to have a Validation Engineer on your team to manage the process, you are ahead of the curve, however it is still a labor-intensive function even for a dedicated resource. https://zurl.co/pmZJ #leaktesting #leakdetection #manufacturing #quality #medical #medicaldevice #medicalequipment #medicalautomation