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Computer Validation Specialist

Somerset, NJ 08873

Posted: 11/17/2022 Employment Type: Contract Job Category: Other Job Number: 517429 Is job remote?: No Country: United States

Job Description


Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documents includes like Data Integrity Assessment, FDA 21CFR Part 11 and EU GMP Annex 11 Assessment, Computer System Validation Plan, System Requirement Specification (SRS), System Impact Assessment (SIA), Data Integrity Assessment (DIA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.
  • Ensure that site Computer System Inventory list is maintained per corporate format and remain in current state.
  • As a Subject Matter Expert (SME), Computer System Validation Specialist should be a site computer system administrator for equipment and instrument computer systems.
  • Generate validation protocols and summary reports in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
  • Generate a CSV validation plan detailing the scope of work and intent.
  • Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
  • Ensure all work is in line with the site Validation Master Plan, regulations, procedures, and practices.
  • Ensure that the site Validation Master Plan remains current and aligned with corporate policies as it applies to CSV polices/standards.
  • Generate and maintain site Computer System Validation procedures in line with corporate guidelines, cGMP, corporate policies/standards and ISPE GAMP 5 guideline.
  • Lead and conduct validation activities in compliance with US and EU regulations, (regulations for all countries where have business) procedures, and EHS requirements.
  • Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
  • Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.
  • Liaise with manufacturing and laboratory groups in execution of the Validation program.
  • Communicate Computer System Validation approaches and requirements during audits.
  • Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments.
  • Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures.
  • Track and resolve deviations/exceptions during qualification activities.
  • Prioritize qualification activities in line with the project schedules and timelines.
  • Co-ordinate validation/qualification activities with key stakeholders.
  • Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise.
  • Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company.
  • Manage Validation contractors to complete on-site validation if required.
  • Other tasks as assigned.

POSITION REQUIREMENTS:

Education & Experience:
  • A Bachelors degree with at least 3+ years of experience or Associate degree with at least 5 to 7 years of experience working in the pharmaceutical industry (regulated by GMP standards and requirements).
  • Direct experience in the validation of computerized systems in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations is highly preferred.
  • Experience in Computer/Software validation (Prepare IQ, OQ, PQ protocol.
    Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documents includes like Data Integrity Assessment, FDA 21CFR Part 11 and EU GMP Annex 11 Assessment, Computer System Validation Plan, System Requirement Specification (SRS), System Impact Assessment (SIA), Data Integrity Assessment (DIA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.
  • Ensure that site Computer System Inventory list is maintained per corporate format and remain in current state.
  • As a Subject Matter Expert (SME), Computer System Validation Specialist should be a site computer system administrator for equipment and instrument computer systems.
  • Generate validation protocols and summary reports in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
  • Generate a CSV validation plan detailing the scope of work and intent.
  • Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
  • Ensure all work is in line with the site Validation Master Plan, regulations, procedures, and practices.
  • Ensure that the site Validation Master Plan remains current and aligned with corporate policies as it applies to CSV polices/standards.
  • Generate and maintain site Computer System Validation procedures in line with corporate guidelines, cGMP, corporate policies/standards and ISPE GAMP 5 guideline.
  • Lead and conduct validation activities in compliance with US and EU regulations, (regulations for all countries where have business) procedures, and EHS requirements.
  • Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
  • Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.
  • Liaise with manufacturing and laboratory groups in execution of the Validation program.
  • Communicate Computer System Validation approaches and requirements during audits.
  • Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments.
  • Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures.
  • Track and resolve deviations/exceptions during qualification activities.
  • Prioritize qualification activities in line with the project schedules and timelines.
  • Co-ordinate validation/qualification activities with key stakeholders.
  • Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise.
  • Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company.
  • Manage Validation contractors to complete on-site validation if required.
  • Other tasks as assigned.

  • POSITION REQUIREMENTS:

    Education & Experience:
  • A Bachelors degree with at least 3+ years of experience or Associate degree with at least 5 to 7 years of experience working in the pharmaceutical industry (regulated by GMP standards and requirements).
  • Direct experience in the validation of computerized systems in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations is highly preferred.
  • Experience in Computer/Software validation (Prepare IQ, OQ, PQ protocol.
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