Data Validation Specialist

4 days ago

Brisbane, Queensland, Australia beBeeValidation Full time $120,000 - $180,000
Job Overview

We are seeking a skilled Computer Systems Validation Engineer to develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution.

This role involves writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Responsibilities
  • Prepare and review validation documentation related to projects and change controls.
  • Manage change controls and other compliance-related tasks.
  • Participate in the review of current and future CSV procedures and policies.
  • Analyze the results of testing and determine the acceptability of results against predetermined criteria.
  • Investigate and troubleshoot problems that occur and determine solutions or recommendations for changes and/or improvements.
  • Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinate with other departments or outside contractors/vendors to complete validation tasks.
  • Participate in regulatory audits and communicate the company's computer validation policies.
  • Assess the company's computer systems and identify any potential Part 11 or Annex 11 gaps.
  • Manage projects and prepare status reports using Microsoft Project and other communication tools.
  • May supervise, lead, or manage lower-level personnel.
Requirements

BS in a Computer Science or Engineering field or equivalent experience.

Minimum 2-7 years' experience with Computer Systems Validation.

Minimum 2-7 years' experience working in a GMP environment.

Experience in Data Integrity with GAMP and 483, compliance, deep 21 CFR Part 11 experience highly desired.

Experience in biotech and pharma is preferred over medical device.

Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients.

Excellent oral and written communication skills in English/Fluent in English.

Able to travel domestically and internationally as required.

Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.

High attention to detail.

Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.

Independent individual and yet a strong team player.

Benefits

Highly Competitive Salary.

Continuing education (internal and external).

Opportunities to work on cutting-edge projects in a highly evolving field.

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