Sr. IT Qualification Engineer

Title: Sr. IT Qualification Engineer

Duration: 7 months

Location: Newark, CA, 94560

Job Summary

The incumbent will be a part of the IT R&D Department and will perform and/or direct IT Infrastructure Qualification projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual will ensure that GxP systems & underlying IT infrastructure meet the intended use and comply with applicable regulations, current industry practices, and client's policies and procedures. Qualification or Validation projects will primarily include IT Infrastructure but may include projects from other departments that support GxP operations.

Essential Duties/Responsibilities

• Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts
• Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work
• Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities
• Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts
• Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary
• Perform gap analysis & necessary remediation efforts on current IT Infrastructure to ensure compliance with Part 11 and Annex 11
• Collaborate/lead/participate in decision-making and make recommendations regarding the best options for the qualification of computerized systems. Maintain close communication with stakeholders and team members to keep apprised of IT Infrastructure needs, & impact on GxP processes or operations
• Collaborate with client-approved vendor personnel in coordinating qualification or validation efforts to ensure successful system implementations
• Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted
• Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments, etc.
• Assist IT staff with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems
• Perform periodic system reviews ensuring that the systems are maintained in their validated state
• Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV
  
  

Education

Minimum Required: Bachelor's degree in Engineering, Science or a related technological field

Preferred: Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS) or any related field.

Experience

Minimum Required:

• Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience
• Understanding of the Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements
• Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10
• Demonstrate ability to effectively manage multiple projects/priorities and a good understanding of SDLC phases and phase gates
• Experience with EDMS, VLMS, LMS, and working knowledge of IT Infrastructure systems (AD, Backups, VMware, Monitoring at minimum)
• Demonstrate excellent written and oral communication skills.
• Effective time management and interpersonal skills.
• Must work effectively within teams with rapidly changing priorities.
• Demonstrates analytical problem-solving skills.
  
  

Preferred

• Relevant validation experience with Quality Systems, Manufacturing Systems, or Laboratory systems used within the pharmaceutical industry is a plus.
  
  

Knowledge, Skills, And Abilities

Minimum Required: Risk Management Tools, MS Word, Excel, PowerPoint, Visio, Project, and Outlook. About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.