• Consulting
  • Chesterbrook
  • Close: 2019-06-24

Description:


Role: Computer System Validation Engineer I

Description

Under the general direction of the Manager, SQA and Validation, the Computer System Validation (CSV) Engineer is responsible for the implementation of ABC’s CSV strategy and leading validation efforts on computerized systems (hardware and software) to support business systems that have GxP impact, ensuring compliance with 21CFR11 requirements is established and maintained. This includes working as a technical lead on multiple projects, estimating, prioritizing, executing, maintaining, and coordination of CSV activities, evaluation of software applications against design specifications and user requirements, and serves as the liaison between the appropriate IT, operational business units and external partners on validation activities, in order to ensure project expectations are properly set and met as per company policies and procedures.

What You'll Do:

• Ensures validation policies and standards are followed.

• Implements CSV strategy and lead validation efforts on computerized systems to support our business systems that have GxP impact, ensuring compliance with FDA 21CFR Part 11 and other regulatory requirements is established and always maintained.

• Effectively manages all assigned computer validation projects, enhancements, and requests for change, including the review of high level estimates from IT/PM to ensure QA timelines provided/forecasted are consistent with the expected project completion date. Complete assigned projects and tasks within agreed deadlines.

• Reviews and/or assists in developing validation strategies and associated documentation against the requirements of our CSV Policy and Procedures ensure that compliance and business needs are achieved.

• Prepares validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Validation Plan, Requirements Traceability Matrix, Risk Assessments, IQ/OQ/PQ Testing Protocols, Test Cases, Validation Summary Report, Change Control, etc.

• Prepares and submits validation estimates and project schedules.

• Determines validated testing requirements, creates, updates, and maintains validated related test artifacts and approval signoff signatures.

• Evaluates changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.

• Participates in requirement/design reviews or sprint/release planning sessions; identifies gaps and probes for detailed explanation of expectations.

• Evaluates testability of business and technical requirements based on business/functional requirement document(s), use cases, user stories and/or solution design documents.

• Assists internal and external auditors in FDA compliance reviews.

• Designs/creates and execute test cases (e.g., functional tests, integration tests, challenge tests, regression tests, etc.) and setup data for tests scripts that are appropriate to the risks and purpose of the applications and enhancements and ensure logged defects are resolved.

• Coordinates and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review.

• Maintains computer system validation documentation and archiving ensuring effective document retrieval when required.

• Provides quality guidance and assessment to ensure maintenance of validated systems are managed in accordance with current corporate and regulatory requirements.

• Participates in planning workshops as well as test readiness and test result reviews.

• Communications/ Consulting Supports and participates in the formal reporting of project status.

• Participates in lessons learned sessions.

• Participates in short- and long-term project planning efforts with team members, clients and other IT groups.

• Reviews and provide input, where required, to CSV-related Standard Operation Procedures and policies.

• Monitors and analyzes testing process metrics for continuous improvement.

• Coordinates with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, practices and tools. This may include formal preparation of training materials, one-on-one training, and classroom training.

Qualifications

Requires 5–7 years of related information technology work experience and a minimum of 5 years of Quality Assurance and Quality Control experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment with extensive experience in a matrixed environment and interactions with external vendors. A college or university degree in computer sciences (e.g. IT, information security, engineering, software programming, etc.) is required.

Personal Attributes

• Ability to communicate effectively, both orally and in writing.

• Ability to prioritize work load and consistently meet deadlines

• Ability to resolve enterprise level system and project issues effectively and efficiently.

• Demonstrated experience documenting and executing testing policies and standards.

• Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits).

• Excellent organizational skills; attention to detail

• Excellent teamwork and interpersonal skills; leadership and relationship building skills.

• Experience leading teams and demonstrates continuing professional development.

• Experience with SAP Advanced Track and Trace for Pharma (ATTP) is an asset.

• Expert understanding of script execution and reporting.

• Hands-on experience in validation of GxP systems.

• Keep current with relevant industry and regulatory guidelines.

• Expert knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11 and other harmonized international guidelines (PIC/S, ICH) and GxP.

• Strong analytical, problem-solving and conceptual skills.

• Strong knowledge of relevant technology, tools and software; SDLC, Desktop services, TFS, HP Test tools, Zephyr/Jira or equivalent testing tools.

• Working knowledge of Secure Supply Chain (SSC) and Drug Supply Chain Security Act (DSCSA). processes.

Location: Onsite, Chesterbrook, Pennsylvania.

*** ADDITIONAL NOTES ON WHAT TO FOCUS ON FROM THE MANAGER ***

• Demonstrated understanding and experience producing quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits) deliverables for computer solutions used by the pharmaceutical industry.

• Expert knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11 and other harmonized international guidelines (PIC/S, ICH) and GxP.

• Working knowledge of the US Drug Supply Chain Security Act (DSCSA) and other track and trace regulations, processes, and systems is an asset.

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