We have other current jobs related to this field that you can find below

  • Senior Validation Engineer

    3 months ago

    South Plainfield, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities & Requirements: Multiple Positions and systems are available: SDMS/Labx/Veeva RIM/SDMS/ValGenesis/Labware LIMS. Perform "Data Integrity” related- risk assessments. Deviation investigations suggest implementing remediations in CGMP operations. Performs Data Integrity compliance/impact assessments, risk assessments, and...

  • Lead Validation Engineer

    21 hours ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Position: Senior Validation EngineerCompany: Katalyst HealthCares & Life SciencesKey Responsibilities:Engage in multiple roles across diverse systems including SDMS, Labx, Veeva RIM, ValGenesis, and Labware LIMS.Conduct thorough risk evaluations pertaining to Data Integrity.Examine discrepancies and implement corrective actions within CGMP operations.Perform...

  • Lead Computer Systems Validation Engineer

    6 days ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Position: Senior Validation EngineerCompany: Katalyst HealthCares & Life SciencesKey Responsibilities:Engage in various roles across systems including SDMS, Labx, Veeva RIM, ValGenesis, and Labware LIMS.Conduct thorough risk evaluations concerning Data Integrity.Analyze deviations and implement corrective actions within CGMP environments.Perform compliance...

  • Lead Computer Systems Validation Engineer

    21 hours ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Job Title: Senior Validation EngineerCompany: Katalyst HealthCares & Life SciencesKey Responsibilities & Qualifications:Available positions across diverse systems including SDMS, Labx, Veeva RIM, ValGenesis, and Labware LIMS.Conduct thorough risk evaluations concerning Data Integrity.Examine deviations and execute corrective actions within CGMP...

  • Lab Systems Validation Specialist

    15 hours ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Department, overseeing and executing GxP computerized system validation initiatives in alignment with current Good Manufacturing Practices (cGMP), applicable regulations, and industry standards. This role is crucial in ensuring that GxP systems fulfill their...

  • Lab Systems Validation Specialist

    6 days ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in accordance with cGMP, CFR Part, and Annex regulations. This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations,...

  • Lab Systems Validation Specialist

    15 hours ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in alignment with cGMP, CFR Part, and Annex regulations. This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations,...

  • Sr. Airframe Design Engineer

    1 month ago

    South Burlington, United States Beta Technologies Full time

    At Beta Technologies, we apply our intellectual curiosity, passion for aviation, and commitment to sustainability toward a shared mission of revolutionizing electric aviation. Regardless of the position one holds, each team member brings their talent and desire to positively impact the environment and lives of others in a refreshing, vibrant, and inclusive...

  • Lead Geotechnical Engineer

    17 hours ago

    South Plainfield, New Jersey, United States Hillis-Carnes Full time

    Job Title: Lead Geotechnical EngineerHillis-Carnes Engineering Associates (HCEA) is a distinguished engineering firm known for its commitment to excellence in the mid-Atlantic region. As a fully employee-owned organization, we emphasize collaboration, ambition, and avenues for professional advancement.Key Responsibilities:Execute test boring and pit...

  • Lead Protection Engineer

    5 days ago

    South Plainfield, New Jersey, United States Milhouse Engineering and Construction, Inc. Full time

    Company Overview:Milhouse Engineering & Construction is expanding its operations and is in search of a Senior Protection & Controls Design Engineer to take on reviewing responsibilities.This position is hybrid and will be based in South Plainfield, New Jersey.Role Responsibilities:As a Senior Protection & Controls Design Engineer, you will:Design protection...

  • Principal Geotechnical Engineer

    6 days ago

    South Plainfield, New Jersey, United States Biz First Full time

    Job Overview Senior Geotechnical Engineer BizFirst is collaborating with a prominent client to recruit a Full-time, Direct Hire Senior Geotechnical Engineer. This role is based in South Plainfield, NJ, focusing on projects primarily within the region, with occasional travel throughout the surrounding areas. Our client is a dynamic, mid-sized consulting...

  • Senior Geotechnical Engineer

    3 months ago

    South Plainfield, United States Hillis-Carnes Full time

    Job DescriptionJob DescriptionWHO IS HILLIS-CARNES?Hillis-Carnes Engineering Associates (HCEA) is a multi-disciplined ENR Top 500 engineering firm with 20 offices in the mid-Atlantic. We have a demonstrated history of success for the past 35 years. We are 100% employee-owned ESOP, and our history of success can be attributed to our motivational employee...

  • Process Validation

    3 months ago

    South Boston, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Client is looking for a Senior Process Validation consultant who has some TMV experience. They are good on the process engineering side and the consultant will be responsible for writing/executing process validation protocols. Wants to see a strong documentation and writing background, core of the job. Will run some PQs and...

  • Senior Control Engineer

    3 months ago

    Plainfield, United States Sterling Engineering Full time

    DescriptionOne of our clients has an excellent career opportunity for a Sr. Controls Engineer. They are looking for a highly skilled and dedicated individual to join our talented growing team.ResponsibilitiesThe right candidate will have a high mechanical aptitude and the ability to work in a fast-paced environment with skills in the following areas:· The...

  • Senior Control Engineer

    3 months ago

    Plainfield, United States Sterling Engineering Full time

    DescriptionOne of our clients has an excellent career opportunity for a Sr. Controls Engineer. They are looking for a highly skilled and dedicated individual to join our talented growing team.ResponsibilitiesThe right candidate will have a high mechanical aptitude and the ability to work in a fast-paced environment with skills in the following areas:· The...

  • Lead Geotechnical Engineering Specialist

    6 days ago

    South Plainfield, New Jersey, United States Biz First Full time

    Job Overview Senior Geotechnical Engineer BizFirst is collaborating with a client to recruit a Full-time, Direct Hire Senior Geotechnical Engineer. This role will be based in South Plainfield, NJ, primarily focusing on projects within the state, with occasional travel across the tri-state region. Our client is a dynamic, mid-sized consulting engineering and...

  • Geotechnical Engineering Project Leader

    16 hours ago

    South Plainfield, New Jersey, United States Spotlock Full time

    Job OverviewPosition Summary:We are looking for a motivated and career-oriented professional to take on the role of Geotechnical Project Manager at Spotlock.The Geotechnical Project Manager will oversee client relationships and project execution, ensuring the development of geotechnical engineering documentation, calculations, and specialized inspections...

  • Senior Geotechnical Engineer

    2 weeks ago

    South Plainfield, United States S Piper Staffing LLC Full time

    Title: Senior Geotechnical Engineer (Licensed P.E.) Summary: Our client is seeking a motivated, driven Senior Geotechnical Engineer (P.E.) to join their rapidly growing Civil Engineering Consulting Firm in several U.S. locations! The firm focuses on Civil, Geotechnical, and Structural Engineering for Renewable Energy and Infrastructure Projects across the...

  • Validation Engineer

    2 weeks ago

    South San Francisco, United States SDLC Technologies Full time

    Job Description:Only on W2Biosero GBGIgnitionTulipTWD Supplier Quality ManagementThe candidate does not need the full list of experience. They will assign certain projects to a candidate depending on which of the above systems they specialize in. Mid-level preferred since they will need to work with system owners and create the validation docs with little...

  • Validation Engineer

    2 weeks ago

    South San Francisco, United States SDLC Technologies Full time

    Job Description:Only on W2Biosero GBGIgnitionTulipTWD Supplier Quality ManagementThe candidate does not need the full list of experience. They will assign certain projects to a candidate depending on which of the above systems they specialize in. Mid-level preferred since they will need to work with system owners and create the validation docs with little...

Sr. Validation Engineer

2 months ago

South Plainfield, 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 needs to drive the validation activity close out.
  • ssist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
  • Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations.
  • Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
  • Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
  • Focus of this role will be to Qualify Clean Rooms.
  • Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Requirements:
  • Minimum of 9+years' experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • 1-3 years in a quality assurance or quality control role in an FDA-regulated company.
  • Past experience with balance reports, hepa filter certs, and all associated utilities and equipment.
  • Strong knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable.
  • Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
  • Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
  • Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.