Validation Specialist

Job Description:

• Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
• Follow SOPs and industry best practices
• Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
• Review validation deliverables for projects which are contracted to third party suppliers
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing
• Review computerized systems validation documents such as:
  
  • Requirements Specification
  • Design Specification
  • CSV Risk Assessment
  • Test Plans
  • Test Summary Reports
  • Data Migration Plan
  • Pre/Post Executed Test Scripts
  • Traceability Matrix
  • Release to Production Statements
• Direct and review testing
• Provide guidance on quality issues that affect the integrity of the data or the system
• Obtain and respond to QA review
• Participate in establishing standard quality and validation practices
• Independently assess compliance practices and recommend corrective actions
• Approve validated computer system related change requests
• Monitor regulatory and inspection trends and advise the business on suitable action
• Chould be 50% onsite at either New Brunswick or Lawrenceville.

Qualifications :

• Must have: 5+ years of HP ALM; 5+ years of 21 CFR Part 11 experience; and 5+ years of CSV with Biopharma space
• Ability to create documents to an existing document standard.
• Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
• Advanced knowledge of complete MS Office suite and Visio.
• Firm understanding of technology platforms as needed for project.
• Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
• Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
• Once trained, have the ability to work independently on CSV projects with minimal oversight.
• Ability to perform in a highly matrixed organization structure
• 6+ years' experience
• LIMS implementation.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.