Sr. Validation Engineer III

2 weeks 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 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.)
  • Main 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 5 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.

  • Electrical and Instrumentation Technician I-SR

    1 week ago

    Hopewell, United States City of Hopewell, VA Full time

    Description THIS POSITION IS A CAREER DEVELOPMENT POSITION AND THE SELECTED CANDIDATE WILL BE HIRED AT THE LEVELIN WHICHTHEY MEET ALL MINIMUM QUALIFICATIONSBASED ON THE ESTABLISHED CAREER DEVELOPMENT PROGRAM. SALARY COMMENSURATE WITH EXPERIENCE. Performs difficult to intermediate technical and skilled work installing, calibrating, monitoring, and...

  • Deputy Water Renewal Director

    2 weeks ago

    Hopewell, United States City of Hopewell, VA Full time

    Description Performs difficult professional work overseeing the operation and maintenance of the department, managing division programs, managing engineering projects, ensuring compliance with environmental regulations and policies, and related work as apparent or assigned. Work is performed under general direction. Supervision is exercised over all...

  • Sr. Maintenance Technician

    1 week ago

    Hopewell Junction, United States ON Semiconductor Full time

    onsemi located in East Fishkill, NY is seeking a Senior Equipment Maintenance Technician Summary of Role: This equipment engineering position is for an Engineer who will support the LAM Etch production tools. The primary responsibilities of this position are to sustain the manufacturing production line, troubleshoot and repair equipment issues, train...

  • Temporary Registered Nurse URGENTLY HIRING

    4 weeks ago

    Hopewell, United States Sanford Federal Inc Full time

    Job DescriptionJob DescriptionGENERAL INFORMATION INTRODUCTIONThe Bureau of Prisons, FCC Petersburg, intends to make a single award of a firm fixed price task order to a qualified entity to provide temporary nursing services (120 days) to (4) Four Registered Nurses for Federal offenders held in the custody of the Department of Justice, Federal Bureau of...

  • Temporary Registered Nurse

    2 weeks ago

    Hopewell, United States Sanford Federal Inc Full time

    GENERAL INFORMATION INTRODUCTION The Bureau of Prisons, FCC Petersburg, intends to make a single award of a firm fixed price task order to a qualified entity to provide temporary nursing services (120 days) to (4) Four Registered Nurses for Federal offenders held in the custody of the Department of Justice, Federal Bureau of Prisons, at the Federal...