Sr CSV Engineer

Location: Warren, NJ, New Jersey, USA
Salary: competitive
Job Type: Contract
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Title: Sr CSV Specialist

Duration: 6 Months (with possible extensions)

Location: Warren, NJ

MUST HAVES:

  • Experience validating and using stand-alone computerized lab systems
  • Hands-on knowledge of Windows OS basic setup and configuration (group policies, user permissions, registry, etc.)
  • Experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
  • Experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent

Essential Functions:

  • Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures.
  • Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures.
  • Schedules and performs periodic review of validated computer systems
  • Conducts investigations into qualification failures, develops and implements remediation plans
  • Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems
  • Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques.
  • Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity.
  • Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
  • Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates.
  • Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to company standards.
  • Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required.

Knowledge, Skills & Abilities:

  • IMPORTANT - Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
  • Hands-on knowledge of Windows OS basic setup and configuration (group policies, user permissions, registry, etc.)
  • Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements
  • Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
  • Strong experience writing and executing system validation & equipment qualification documents
  • Ability to interact effectively with laboratory personnel, QA, and Facilities groups
  • Maintains a high level of multi-tasking ability in conjunction with proven organizational skills.
  • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously
  • Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization.
  • Extremely proficient at writing well-formulated emails and reports.
  • Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
  • Ability to effectively communicate with employees, contractors and vendors.
  • Strong experience with technical writing and document development / generation
  • Innate ability to learn new software as required for equipment qualification and system validations.
  • Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.

Sthree US is acting as an Employment Business in relation to this vacancy.

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