Computer Systems Validation Engineer

7/18/22

Baltimore, MD

1764

The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation protocols and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. This person will be the data integrity steward and is responsible for operational coordination and implementation of processes necessary to ensure data integrity, data management and data security. Based on the document system and in particular the documents associated with Computer Systems, the data steward's mission will be to contribute to the governance, quality and integrity of the data and metadata managed with the computer systems throughout their life cycle.

Responsibilities:

  • Contribute to the application of the company governance on data integrity.
  • Control and minimize risks to data integrity.
  • Develop action plans to remediate failures associated with the principles of data integrity.
  • Provide cGMP and Data Integrity coaching to site to ensure compliance with data lifecycle and performance requirements to achieve DI strategy.
  • If applicable, verify that the backup/restore and archiving processes are operational.
  • Maintain the list of rights assigned per user.
  • Ensure that people accessing the computer systems have the appropriate training and authorizations.
  • Participate in the verification of the maintenance of the "validated" state of the computer systems.
  • Conduct internal audits related to data integrity.
  • Ensure periodic reviews are conducted and updated as necessary.
  • Participate in audit trail reviews.
  • Participate in impact studies and risk analyses when evaluating and updating computer software systems or changing processes.
  • Utilize the company’s change management program to appropriately assess change.
  • Familiarity with cloud based systems such as Azure and AWS.
  • Support supplier qualifications of cloud based providers.
  • Drive to solutions while promoting IT in partnership with QA to establish quality culture as it relates to computerized systems.
  • Execute other projects as assigned by the Director of Quality.

Requirements:

  • BS in a Computer Science or Engineering field or equivalent experience
  • Minimum 3-5 years' experience with Computer systems validation in the USA
  • Minimum 3-5 years' experience working in a GMP environment
  • Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience is highly desired
  • Experience in biotech and pharma is preferred over medical device
  • Experience with FactoryTalk, Siemens and their associated platforms, Rockwell and associated platforms, Xenon, Waters Empower, Systech serialization systems, Oracle EBS, LIMS and QMS systems.
  • Has exceptional written and verbal communication skills.
  • Can exercise strong problem-solving skills and analytical thinking.

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