Validation Expert

**Summary**:
**Role Responsibilities**:

- Provides technical and compliance expertise for strategy/execution of computer systems validation in accordance with various regulatory standards or guidance (e.g., 21 CFR Part 11, 211, 820, GAMP, CSA).
- Performs IT change control impact assessments and work with IT and business SMEs
- Represents IT in company change control meetings for new/existing IT solutions.
- Develops some parts or all computer system validation project documentation and artifacts.
- Takes the project lead and/or business analyst role for assigned projects and initiatives related to compliance improvements, remediations, and design/build of new compliance processes.
- Runs small to large, simple to complex, computer system validation efforts.
- Provides coaching and guidance to various system and project stakeholders on computer systems validation best practices, risk management, and industry guidance.
- Advises on IT project execution and IT infrastructure operations from a risk and compliance point of view.
- Provides IT audit support for internal and external audit entities (e.g., TGA, FDA, CBOH, MHRA) regarding board of health regulations, standards, and practices
- Stays current on computer systems validation approaches, industry trends, and board of health agency guidance.
- Provides software supplier assessments support to evaluate suppliers for engagement related to IT systems and processes used within the manufacturing and quality plane
- Oversees junior roles, staff augmentation, or vendor services contracted or procured for execution of computer systems validation on larger projects.
- Takes ownership for some or part of IT life cycle compliance operations to ensure periodic activities are completed with quality and on time and systems stay fit for purpose.
- Develops, maintains, or improves controlled IT documents and procedures to align new IT services/operations or to fill operational compliance gaps.

**Example Experiences Sought**:

- Operated as the computer systems validation strategy lead on multiple, complex systems in a biopharma, manufacturing environment.
- Delivered computer system validation packages for IT lab, IT Quality, and IT manufacturing systems as lead validation engineer.
- Designed IT-regulatory compliance processes and operational improvements.
- Performed extensive risk managements and gap-remediation on IT systems and processes to align validation life cycles with board of health agency expectations and industry standards.
- Executed data integrity business programs and/or remediation projects.
- Executed computer systems validation within an SDLC, iterative framework.
- Worked closely with IT / technical SMEs providing coaching on computer systems validation and compliance operations, changing culture, winning hearts and minds.

**Required Qualifications**:

- Bachelor's degree in Computer Science, IT, or science-related discipline
- Proficient in English
- 8+ years of experience in pharma/device or other pharma regulated industry in IT related support functions specifically validation of laboratory, quality or manufacturing related IT systems.
- Deep knowledge of lab systems, plant manufacturing systems, quality systems, Document Management Systems, CAPA processes, risk management and audits typical for a pharmaceutical manufacturing operation.
- Clear, sustained experience with SDLC/GAMP and IT project management methodologies; Agile cGMP development is a plus.
- Training and knowledge of FDA CSA a plus.
- Lean Six Sigma and/or ASQ certification a plus.