5 days old

CSV ENGINEER IV

LSNE
BEDFORD, New Hampshire
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

JOB SUMMARY

The CSV Validation Engineer IV will lead the full lifecycle of validation projects including but not limited to delivering on time and to specification ensuring the delivery of a quality validation project at all times. Author and review all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, and Configuration Specifications. Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, site quality management system, and current industry practices. The CSV Validation Engineer IV is responsible for generating, reviewing and approving system assessments, test scripts, change controls, process improvements and compliance governance at all applicable points of the system life cycle for all LSNE sites.. In addition, this individual will serve as the SME to provide compliance leadership and oversight for CSV projects. Collaborate with departments -within the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.

 

JOB DUTIES –

  • Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.

  • Responsible for protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated to validated computer systems

  • Work with Gap Assessments and remediation plans with an applying risk management principles.

  • Supports regulatory and client audits as CSV SME.

  • Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.

  • Performs periodic reviews and ongoing support of validated systems post Go-Live.

  • Perform revalidation and change control validation related activities.

  • Responsible for executing and reviewing CSV activities including projects associated with PCS, BMS, CMS, OSI PI, and other automation upgrades.

  • Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.

  • Provide training to colleagues and contractors on approach to systems implementation and validation SOP’s.

  • Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.

  • Develop and maintain Validation SOPs, forms, documentation and files.

  • Coordinate and document issues, action items, meeting notes, do appropriate follow up related to CSV projects.

  • Recommend enhancements to project specs

  • Coordinates fulfillment of all requirements for systems audits 

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE –

  • Eight plus (8+) years of relevant automation, engineering, project management or operations experience within a cGMP environment, with at least 5 years of recent automation experience.
  • BS degree or equivalent in technical area preferred and a minimum of 8 plus years’ experience in the validation of computer systems for manufacturing, equipment and process, as well as utilities, and facilities qualification.
  • Experience in the biotechnology and/medical or pharmaceutical industry.Proficiency of Computers Systems Validation and Quality Systems.
  • Good knowledge and skills in engineering of Automation for HVAC/ Clean Media / Process Utility/Monitoring Building Management Systems including system
  • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry.
  • GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
  • Microsoft Office and database management skills.

PHYSICAL REQUIREMENTS -

  • Must be able to sit or stand for prolonged periods of time
  • Must be able to travel between production facilities
  • Ability to work in a fast-paced environment 

COMMUNICATIONS & CONTACTS –  

  • Excellent written and oral communication to include accurate and legible documentation skills.

  • Ability to interface and communicate directly with clients may be required.

     

MANAGERIAL & SUPERVISORY RESPONSIBILITIES - Not Applicable

Categories

Posted: 2019-08-13 Expires: 2019-09-12

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CSV ENGINEER IV

LSNE
BEDFORD, New Hampshire

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