Job Description

Job Title:  Validation Manager

Pay:  $85.00 - $90.00/hour

Job Overview:  The Validation Manager, R&D IT is responsible for implementing a computer software assurance strategy for the R&D IT department.  This includes reviewing and revising the existing processes and procedures, implementing an ALM tool and ensuring its successful adoption within R&D, and developing validation templates.  A successful candidate will have recent CSA experience, an understanding of the regulatory landscape, and familiarity with validating SaaS applications, laboratory instruments and applications, and AI models.

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 principles
•    Ability to review processes and procedures and implement a comprehensive and compliant computer software assurance strategy
•    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 technical documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and informal training documentation
•    Ability to write Validation Templates in accordance with Standard Operating Procedures and relevant Regulatory guidelines
•    Ability to write validation documents to support the implementation of software applications
•    This activity constitutes ~30% of the job description

System Implementation    
•    Ability to implement a GxP SaaS based electronic validation application, including project management and all relevant validation documentation
•    Ability to drive adoption of the new application in accordance with the policies and procedures
•    Validation support for other projects and applications in accordance with policies and procedures
•    This activity constitutes ~60% of the job description

Requirements:
•    Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications 
•    Experience with writing standard operating procedures, validation templates, validation deliverables
•    Experience running projects and strategy initiatives                                           
Minimum Qualifications
•    Bachelor’s Degree in Computer Science / Information Systems or related discipline 
•    At least 3 days in office
•    5 – 7 years of experience in a position of equal scope and responsibility
•    Experience in the pharmaceutical or medical device industry
Preferred Qualifications
•    Recent experience with CSA and ALM implementation
•    Experience with CSA of SaaS applications
•    Experience with CSA of laboratory instruments, IPCs, and applications
•    Experience with CSA or CSV of AI models