About Us: A leader in the Biotechnology industry committed to maintaining the highest standards of quality and compliance. We are urgently seeking an experienced Sr. IT Qualification Engineer to join our IT R&D Department. This role ensures our GxP systems and underlying IT infrastructure comply with cGMP, 21 CFR Part 11, Annex 11, and other relevant regulations.
Job Summary: As part of the IT R&D Department, you will perform and/or direct IT Infrastructure Qualification projects. Your primary responsibility will be to ensure GxP systems and IT infrastructure meet intended uses and comply with applicable regulations, current industry practices, and company policies. Projects will primarily involve IT Infrastructure but may include support for other departments' GxP operations.
Essential Duties/Responsibilities:
- Provide independent technical leadership and accountability for IT Infrastructure Qualification and CSV efforts.
- Ensure quality and compliance in accordance with established procedures and standards by applying critical thinking to 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, and exceptions required as part of qualification/validation efforts.
- Engage with IT stakeholders to support continuous improvements to existing procedures and policies related to compliance, updating them as necessary.
- Perform gap analysis and necessary remediation on current IT Infrastructure to ensure compliance with Part 11 and Annex 11.
- Collaborate, lead, or participate in decision-making and make recommendations for the best options for qualification of computerized systems. Maintain close communication with stakeholders and team members to stay updated on IT Infrastructure needs and impacts on GxP processes.
- Coordinate qualification or validation efforts with approved vendor personnel to ensure successful system implementations.
- Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure required verification and validation efforts are performed.
- Facilitate computer system validation risk assessments, including System level, Requirement level, and System and Data Audit Trail assessments.
- 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 System Periodic Reviews ensuring systems are maintained in their validated state.
- Support regulatory inspections, internal and partner audits, and implement 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, MIS, or any related field.
Experience:
- Minimum Required:
- 5-7 years or more in the pharmaceutical industry with GMP experience.
- Understanding of 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 FDA regulated environments.
- 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, Q10.
- Ability to manage multiple projects and priorities effectively, 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).
- Excellent written and oral communication skills.
- Effective time management and interpersonal skills.
- Ability to work effectively within teams with rapidly changing priorities.
- 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.
#INDMPHARM
Job Types: Full-time, Contract
Pay: $75.00 per hour
Expected hours: 40 per week
Schedule:
Work setting:
Experience:
- Pharmaceutical/Biotechnology: 6 years (Required)
- GMP: 6 years (Required)
Ability to Commute:
Work Location: In person