Current jobs related to Validation Engineer IV - Hopewell Township - Katalyst HealthCares & Life Sciences

  • Senior Validation Engineer

    3 weeks ago

    Hopewell, New Jersey, United States Katalyst Healthcares and Life Sciences Full time

    Key Responsibilities: Oversee quality assurance for the qualification and validation processes concerning equipment, utilities, and facilities. Draft, review, and approve qualification protocols and reports, along with related documentation to support CQV initiatives for new facilities. Drive the completion of validation activities. Assist in the creation,...

  • Senior Validation Engineer

    3 weeks ago

    Hopewell, New Jersey, United States Katalyst Healthcares and Life Sciences Full time

    Key Responsibilities: Oversee quality assurance for the qualification and validation processes related to equipment, utilities, and facilities. Draft, review, and approve qualification protocols and reports, along with necessary documentation to support commissioning, qualification, and validation (CQV) activities for new installations. Drive the...

  • Sr. Validation Engineer III

    4 months ago

    Hopewell, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role also need...

  • Electrical Engineer as Project Lead for Battery Validation and Testing

    7 days ago

    Hopewell, United States Quantum Ventures Full time

    **Job Summary**Quantum Ventures is seeking a highly skilled Electrical Engineer to lead our battery validation and testing efforts as a Project Engineer. As a key member of our development team, you will be responsible for coordinating and executing comprehensive testing programs for high-voltage batteries.**Key Responsibilities**Develop and implement test...

  • Senior Engineer, Validation Commissioning

    3 months ago

    Branchburg Township, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

  • Facilities Validation Specialist

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryThe Senior Facilities Engineer plays a crucial role in delivering engineering support and validation for plant utilities and facilities. This position is integral to cross-functional teams focused on enhancing and refining existing processes. Collaboration with various departments such as Utilities, Manufacturing, Process...

  • Validation Engineer

    1 week ago

    Ada Township, MI, USA, United States Amway Full time

    About the RoleWe are seeking a highly skilled and experienced Validation Engineer to join our Quality Assurance team at Amway. As a key member of our team, you will play a crucial role in ensuring the quality and safety of our products.Key ResponsibilitiesEquipment Qualification and Validation: Author and oversee equipment qualification, process validation,...

  • Commissioning and Installation Engineering Manager

    4 days ago

    Hopewell, United States Plenty Full time

    About Plenty Plenty is on a mission to make fresh, pesticide-free fruits and vegetables more accessible to everyone. Our cutting-edge indoor, vertical farms produce extraordinary yields using a fraction of the land and water outdoor farms need. Nutrient-rich, mouth-watering and locally grown, our crops help people, communities and our planet to be healthier...

  • CNC Machinist IV

    2 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Job SummaryKamatics Corporation is seeking a highly skilled CNC Machinist IV to join our team in a dynamic and fast-paced manufacturing environment. As a CNC Machinist IV, you will be responsible for operating numerically controlled machine tools to perform complex series of progressive machining operations on a diversified line of work to close and exacting...

  • Production Engineer

    1 month ago

    Hopewell, United States Ashland Full time

    shland has an exciting opportunity for a Production Engineer to join our Specialty ingredients G.P., business at our Hopewell, VA location. This is a very visible, significant role within the Company, and the Plant Engineering and Operations functions. This position will report to the Operations Manager, Ethylcellulose (EC) Division.The responsibilities of...

  • Production Engineer

    1 month ago

    Hopewell, United States Ashland Full time

    shland has an exciting opportunity for a Production Engineer to join our Specialty ingredients G.P., business at our Hopewell, VA location. This is a very visible, significant role within the Company, and the Plant Engineering and Operations functions. This position will report to the Operations Manager, Ethylcellulose (EC) Division.The responsibilities of...

  • Senior Manager

    6 days ago

    Hopewell Township, United States Ampcus Incorporated Full time

    About the RoleAmpcus Incorporated is a leading provider of technology and business consulting services. We are seeking a highly motivated and experienced professional to join our team as a Senior Manager - Technology Transfer.Key ResponsibilitiesLead complex technology transfers with a focus on right-first-time execution and risk management.Perform as...

  • Manager - ( Technology Transfer )

    7 days ago

    Hopewell Township, United States Ampcus Incorporated Full time

    Ampcus Inc is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.  Job Title: Manager - ( Technology Transfer )Location(s): Fully Remote role - however, ideal candidate will be within 240 miles of Greenville NC (half               ...

  • Senior Manager

    3 days ago

    Hopewell Township, United States Ampcus Incorporated Full time

    Job Title: Senior Manager - Technology Transfer SpecialistAmpcus Incorporated is a leading provider of technology and business consulting services. We are seeking a highly motivated and experienced professional to join our team as a Senior Manager - Technology Transfer Specialist.Job Summary:The successful candidate will be responsible for leading the...

  • Data Scientist

    2 weeks ago

    Hopewell Township, United States Tata Consultancy Services Full time

    Job TitleData Scientist (in Yrs)7+ YearsMust Have Technical/Functional Skills Python, SQL , Regression Models , MLOPs, scikit-learn, TensorFlow, PyTorch , Good Communication and Analytical AbilityExperience Required10+Roles & ResponsibilitiesAnalyze large and complex datasets to identify trends, patterns, and insights that drive business decisions.Develop,...

  • Skilled CNC Machinist IV

    2 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Job SummaryKamatics Corporation is seeking a highly skilled CNC Machinist IV to join our team in a dynamic and fast-paced manufacturing environment. As a key member of our production team, you will be responsible for operating numerically controlled machine tools to perform complex series of progressive machining operations on a diversified line of work.Key...

  • Manufacturing Engineer II

    1 week ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineer II to join our team at Biogen. As a key member of our manufacturing organization, you will be responsible for designing, specifying, installing, and validating new process equipment, as well as providing technical support and troubleshooting for assigned process equipment.Key...

  • Senior Facilities Engineer

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryThe Senior Facilities Engineer plays a crucial role in providing technical engineering support and validation for plant utilities and facility operations. This position is integral to cross-functional teams aimed at enhancing and optimizing existing processes. Collaborating with various departments such as Utilities,...

  • Ion Implantation Equipment Engineer

    2 weeks ago

    Hopewell Junction, New York, United States Onsemi Full time

    Equipment Engineer - Ion ImplantationJoin Onsemi as an Equipment Engineer focusing on Ion Implantation technology. In this position, you will be tasked with the upkeep and enhancement of semiconductor manufacturing machinery to guarantee effective production workflows. Your responsibilities will include diagnosing equipment challenges, executing preventive...

  • Manufacturing Equipment Optimization Engineer

    2 weeks ago

    Hopewell Junction, New York, United States Onsemi Full time

    Equipment Engineer - Ion ImplantationJoin Onsemi as an Equipment Engineer with a focus on Ion Implantation technology. In this position, you will be tasked with the upkeep and enhancement of semiconductor manufacturing apparatus to guarantee effective production workflows. Your responsibilities will include diagnosing equipment problems, executing preventive...

Validation Engineer IV

4 months ago

Hopewell Township, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities: Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation. Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc. Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed. Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements. Review of equipment specification/design/procurement/installation and validation. Project planning and execution including scheduling, task management, milestone planning and reporting. Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc.). Employee will be required to work closely with both manufacturing, quality, and engineer associates. Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects. Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations. Position flows based on project needs up to and including quality approvals. Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood. Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline). Strong knowledge of cGMP's. Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches. Biotech and/or Sterile manufacturing and aseptic processing knowledge required. Experience in Computerized System Validation (CSV). Biopharma Process Experience Minimum of - years' experience in validation (with degree +: without +), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility. Knowledge of cGMP's and Data Integrity principles. Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership. Good communicator (written and verbal) at all levels. Customer focused. Strong analytical and problem-solving ability. Hands-on approach, with a 'can do' attitude. Able to work under minimal or appropriate supervision level. Ability to prioritize, demonstrating good time management skills. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Self-motivated, with the ability to work proactively using own initiative. Highly Desirable: Good IT skills , Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required. Requirements: Detail oriented individual must be able to work alone and complete tasks without requiring much supervision. Must be able to meet deadlines and produce quality work consistently. Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects. Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will require gowning into the manufacturing suites. Bring equipment in/out of the cleanrooms as per procedure. Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met. CQV experience is a must and good understand Commissioning, Qualification, and Validation protocols and final reports. Able to write final reports and technical deviations, if needed during CQV execution. Skills Required:Validation protocols, Validation engineer, Regulatory compliance, Detail oriented.