Seven Sourcing Limited’s Post

🌟 At LSC, we specialise in connecting professionals with cutting-edge contracts. As we navigate the evolving landscape, certain technical skills stand out as particularly sought after. 🌟 🔄 Technical Transfer - The ability to seamlessly transfer processes from development to production is crucial. Mastery in this area ensures that quality and efficiency are maintained, even as products scale from lab to market. 🚀 New Product Introduction (NPI) - Bringing new products to life requires a strategic approach. Process Engineers with a knack for NPI are instrumental in driving innovation from conception through to commercialisation. 💉 Fill Finish Expertise - In the pharmaceutical manufacturing process, the fill-finish stage is critical. Engineers with expertise in this area are in high demand to ensure the integrity of the final product. 🔄 Change Control Acumen - With the constant evolution of processes and systems, adeptness in change control is a must. Engineers who can manage and implement change effectively are invaluable to maintaining regulatory compliance and product quality. 🔍 Are you a Process Engineer with expertise in these areas? Explore our open roles here: https://lnkd.in/ehvhVJR5 #ProcessEngineering #LifeSciences #TechnicalSkills

Janssen Gurabo is #hiring! If you have experience in Maintenance & Reliability / Asset Lifecycle Management click below to learn more. You can also connect with Christine Orlando if you have any questions.

#OpportunityAlert: Know someone for this job? Could you tag them in the comments to share with them? #hiring #jobseekers #careerists #jobs #careers #jobopportunity #jobopportunities #careeropportunity #careeropportunities courtesy https://lnkd.in/eJFHduU

Industrial equipment, especially CDMO / Pharma-related, requires special treatment due to the technological complexity, dimensions, and size. Just like assembling machinery demands certain skills from a responsible person, the dismantling of this is also a process impossible to perform without professionals. However the dismantling of equipment is often associated with the "need to destroy", dismantling work must be performed by specialists, while strictly observing the security measures. In each case, there must be a comprehensive plan, noting the health and safety and the dismantling sequence. My job, as a construction and engineering project manager, at Gerritsen Projects, is to run this project, establish timelines, allocate resources for the project and facilitate the work so we can meet the needs and goals of the key stakeholders. #lovemyjob #gerritsengroup #haastek #pharma #cdmo #dismantling

#hiring *Director, Engineering (Drug-Device Combo Products)*, Philadelphia, *United States*, fulltime #jobs #jobseekers #careers #Philadelphiajobs #Pennsylvaniajobs #Engineering *Apply*: https://lnkd.in/gMesTF7p 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

#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

In plant design projects, complexities may appear due to elaborate engineering, specialized equipment, and intricate process flows. Managing these requires focused and in-depth expertise in process engineering, equipment specification and selection, and regulatory and standards compliance. We understand the critical role of project management in transforming visions and plans into outcomes and impact. Here's an overview of our approach: ✔️Project Qualification - understanding the client's perspective and evaluating the feasibility. ✔️Project Initialization - setting performance benchmarks in terms of time, cost, and effort and comprehensive risk assessment. ✔️ Project Planning - crafting a resilient project structure plan having in mind goals and risks. ✔️Project Execution & Controlling - executing project tasks, monitoring progress and resources, and regular reporting to keep stakeholders informed and involved. ✔️Project Closure - delivering the project results for customer acceptance, documentation, and project reviews. The "lessons learned" approach ensures continuous improvement and quality upgrades in each of our future endeavors. At Helmchron, we prioritize delivering at every stage of the project lifecycle. To learn more about our expertise and references ➡️office@helmchron.com ❓Where do you face challenges in project management most often? Share in the comments. #ProjectManagement #Engineering #IndustrialEngineering #ChemicalEngineering #ProcessEngineering #Manufacturing #TeamHelmchron #PlantDesign #GMP #Pharmaceuticals #Chemicals 

To learn more about any of our current roles, reach out to Ashly Clark or Lena Edwards! #precisionmachining #ehs #maintenance #facilitiesmanagement #hrleaders #supplyplanner #demandplanner #plantmanagers #manufacturingcareer #safety #leansixsigmablackbelt #leanmanufacturing #manufacturing #metalmanufacturing #plasticmanufacturing #chemical #meddevice #operationalexcellence #productengineer #OPEX #leansixsigmablackbelt