Senior Computer System Validation Specialist

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Job Overview

The Senior Computer System Validation Specialist role at Rochester Regional Health is primarily focused on ensuring compliance with regulatory expectations for GxP-regulated computerized systems. This position entails leading the planning, execution, and documentation of validation activities, and it is a full-time remote opportunity requiring a commitment of 40 hours per week.

Key Responsibilities

As a Senior CSV Specialist, your duties include:

• Leading the development and execution of validation deliverables for new systems, upgrades, and changes. This will encompass various documentation such as User Requirements Specifications (URS), Functional Specifications (FS), Validation Plans (VP), and risk assessments.

• Carrying out tests and managing any defects to ensure thorough and precise documentation of validation evidence.

• Ensuring that the systems comply with regulatory standards including the US FDA Computer Software Assurance Guideline, GxP (Good Manufacturing Practice/Good Laboratory Practice/Good Clinical Practice), 21 CFR Part 11, EU Annex 11, and ISPE GAMP 5 standards.

• Supporting internal and external audits by providing expert knowledge on CSV deliverables and processes.

• Collaborating with various departments such as Quality Assurance, Quality Control, Engineering, Manufacturing, and IT to ensure robust validation of computerized systems.

• Assisting in the management of system lifecycle activities, including change control and system retirement processes.

• Providing training and mentorship to junior validation specialists and enhancing validation processes and best practices.

Required Qualifications

To qualify for the Senior Computer System Validation Specialist position, candidates must possess:

• A minimum of 5 years of experience in life sciences, focusing specifically on computer systems validation in fields such as biotech, pharmaceuticals, or medical devices.

• A Bachelor’s degree in a relevant field such as Engineering, Computer Science, Information Systems, Life Sciences, or related discipline.

Preferred Qualifications

Candidates with the following qualifications will stand out:

• 7-10 years of practical experience with CSV or GxP system validation within pharmaceuticals, biotech, or medical devices environments.

• At least 1 year of experience operating under the new US FDA CSA Guideline.

• Strong working knowledge of validation lifecycle, methodologies, and current GxP requirements. Experience with various computerized systems, including laboratory, quality assurance, and clinical systems is advantageous.

• Completion of GAMP 5 training or equivalent CSV coursework.

• ASQ certifications (e.g., CSQE, CQA, CQE) and project management certifications (PMP, Agile) are a plus.

Salary and Benefits

The role provides a competitive salary range of $130,000 to $155,000 annually. The pay will be determined based on experience, qualifications, specialty, internal equity, and several other factors.

Work Environment

This position is fully remote, allowing for flexible working conditions. The working schedule is from Monday to Friday, contributing to an excellent work-life balance.

Employer Commitment

Rochester Regional Health emphasizes equal opportunity in its hiring practices, ensuring that all applicants receive consideration without regard to race, color, creed, religion, sex (including pregnancy and childbirth), sexual orientation, gender identity or expression, national origin, age, disability, and other protected characteristics.

Conclusion

In conclusion, the Senior Computer System Validation Specialist position at Rochester Regional Health presents an excellent opportunity for qualified professionals aiming to contribute to the healthcare sector. With competitive compensation, a supportive work environment, and the chance to work remotely, this role is ideal for individuals looking to make an impact in the field of computer system validation and compliance.

Whether you are a seasoned validation specialist or looking to advance your career in the life sciences industry, this position provides a pathway for growth and continuous improvement.

This job offer was originally published on himalayas.app