Principal Engineer, IT CSV

Job description:

New Job responsibility:

• Leads Computer System validation activities including review and approval of computer system validation plans and reports, changes control of computer systems and other related activities.
• Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
• Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
• Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ANNEX 11. ISO 27001, ISO 27002).
• Identify and qualify all computer systems which impact cGMP operations using a risk-based and critical thinking methodology
• Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Execution of validation plans and validation documents
• Coordinate and execute performance and functional testing associated with multiple concurrent developments and/or infrastructure projects.
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Ensure initiation/preparation and closeout of all CSV-related deviations, discrepancies, and change control documents.
• Work with overall project manager to include validation activities in implementation timelines
• Work closely with the Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
• Follow up and Review CSV observations related to IT systems

Qualifications: Candidates must have

• BS in Engineering, Science or equivalent technical degree.
• 8+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
• Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, CSV, etc.), Quality Systems (Change Control, Requalification, etc).
• Excellent written and verbal communication skills; excellent technical writing skills.
• Strong interpersonal skills and the ability to work in a team environment.
• Ability to work effectively in a fast-paced multitasking environment.
• Strong working knowledge of FDA and cGMP regulations and documentation practices.

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