Job Description
Job Description
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Validation Specialist.
Job Description:
Job Title: Validation Specialist
Job Type: Contract
Job Location: Raleigh, NC
Work Schedule: Onsite
Pay Rate: $66, Based on experience
Description:
The Validation Specialist, Regulatory is responsible for implementing GxP computerized systems for the R&D IT department. A successful candidate will have recent CSA experience, an understanding of relevant US and EU regulations, and familiarity with validating SaaS applications, and AI models. Direct experience with electronic Instructions For Use and electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency management are preferred.
Validation Strategy
• Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations
• Subject matter expertise in computer software assurance (CSA) principles
• Ability to review processes and procedures and implement GxP computerized software in a compliant manner
• Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships
• This activity constitutes ~10% of the job description
Technical Writing
• Ability to write validation documents to support the implementation of software applications including change controls, validation plans, user requirements, and testing documentation
• Ability to write training documentation, User and Admin SOPs, as applicable
• Experience with electronic validation applications preferred
• This activity constitutes ~40% of the job description
System Implementation
• Ability to implement GxP computerized systems, including project management configuration, user acceptance testing, and hypercare
• Ability to drive user adoption of the new application through training and change management
• Ability to maintain the validated state of applications in accordance with policies and procedures
• This activity constitutes ~50% of the job description
Technical & Functional Skills:
• Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications
• Experience with writing standard operating procedures, validation deliverables, training material
• Experience running projects and strategy initiatives
Minimum Qualifications:
• Bachelor’s Degree in Computer Science / Information Systems or related discipline
• 3 – 5 years of experience in a position of equal scope and responsibility
• Experience in the pharmaceutical or medical device industry
Preferred Qualifications:
• Experience with Medical Device Regulatory Submissions and applications used by Regulatory Affairs teams
• Experience with CSA validation of SaaS applications
• Experience with CSA or CSV validation of AI models
Physical Requirements:
This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Harkirat Singh for more details.
\nCompany Description
Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002. We provide technology consulting and staffing services to Fortune 500 companies across the country. We collaborate with clients to design, develop and implement business-driven technology solutions. We have deep domain expertise with multiple big data platforms and have strong partnerships with industry leaders in the space. The founders have over 40 years of experience helping clients and consultants succeed. Our commitment is to provide customers with an honest, personalized, face-to-face, long-term relationship and provide consultants with ethical, respectful, and stress-free care. We believe in the power of building successful careers for everyone.
Specialties:
Staff Augmentation
Professional Services - Artificial Intelligence, Big Data Analytics, Mobile Solutions, and Cloud Solutions
Outsourced Services, Administration and Support
Contingent Workforce Services
Company Description
Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002. We provide technology consulting and staffing services to Fortune 500 companies across the country. We collaborate with clients to design, develop and implement business-driven technology solutions. We have deep domain expertise with multiple big data platforms and have strong partnerships with industry leaders in the space. The founders have over 40 years of experience helping clients and consultants succeed. Our commitment is to provide customers with an honest, personalized, face-to-face, long-term relationship and provide consultants with ethical, respectful, and stress-free care. We believe in the power of building successful careers for everyone. \r\n\r\nSpecialties: \r\nStaff Augmentation \r\nProfessional Services - Artificial Intelligence, Big Data Analytics, Mobile Solutions, and Cloud Solutions\r\nOutsourced Services, Administration and Support \r\nContingent Workforce Services