Computer Systems Validation

2 weeks ago

Devens, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Oversee the qualification of process automation systems, laboratory and manufacturing instruments,
  • manufacturing execution systems, databases.
  • Interface with Engineering, Validation, and end user groups as a QA subject matter expert to provide technical
  • validation guidance related to GxP compliance, design and requirements development, testing, system
  • dministration, data management, and risk-management.
  • Oversee the development, implementation, and maintenance of site procedures and policies for Validation,
  • ligning with global policies and procedures.
  • Review and approve validation plans, qualification protocols and test scripts, user acceptance testing, reports,
  • change management, and authorization for use documentation.
  • Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation
  • Master Plan (VMP) adherence.
  • Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility
  • nd participate in resulting investigations and correction / corrective action planning.
  • Verify compliance with applicable Client Policies, Guidelines and Directives and ensures consistency with other
  • site procedures and/or specifications.
Requirements:
  • Knowledge of science is generally attained through studies resulting in a Bachelor's degree in a scientific or engineering discipline or its equivalent.
  • minimum of 9 years' experience in an environment governed by cGMPs, in validation (equipment, facilities,
  • computer systems) or quality assurance validation role overseeing equipment and computerized systems
  • validation
  • Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
  • Firm understanding of quality systems
  • Proficiency in the use of software applications including electronic validation documentation systems (such as ValGenesis, and Maximo)
  • Demonstrated interpersonal, communication, and motivation skills.
  • Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem
  • solving, conflict management, planning and organizing, and analytical thinking.
  • Knowledge of temperature mapping, manufacturing execution systems such as Syncade, and distributive control
  • systems such as DeltaV is required
  • Effective written and verbal communication skills
  • Development Value
  • Gain experience in Cell Therapy and operations
  • Interface with many functional areas including Manufacturing Sciences and Technology, Digital Plant, Manufacturing, Validation, Quality

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