Our multinational client is currently seeking a CSV Engineer for a contract position within the pharmaceutical industry in the mid-west. Attractive rate on offer.
Summary: This position uses policies and procedures to validate/qualify computer enterprise systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties & Responsibilities:
· Prepares/reviews validation documentation related to projects/change controls.
· Manages change controls and other compliance related tasks e.g. non-conformances.
· Participates in the review of current and future CSV procedures and polices
· Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
· Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
· Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
· Coordinates with and guides other departments or outside contractors/vendors to complete validation tasks.
· Supports regulatory audits and communicates company’s computer validation policies.
· Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps or Data Integrity.
· Manages projects and prepares status reports using Microsoft project and other communication tools (e.g. Project Place).
· May supervise, lead, or manage lower-level personnel.
Education & Experience:
· Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
· Experience in a GMP environment essential.
· Biologics experience highly desirable
· Experience in Part 11 or Annex 11 or Data Integrity assessment completion
· Experience in Enterprise validation highly desirable
· Knowledge of Infrastructure qualification highly desirable
· Knowledge of Cloud services qualification/validation.
Clicking the “Apply Now” button means that you agree to the processing of your personal data for the purposes of current and future recruitment processes, carried out by QPTech in accordance with the provisions of the General Data Protection Regulation (GDPR) (EU) 2016/679.You also agree to share your personal data with other entities of QPTech and potential employers for purposes related to the recruitment process. QPTech may also contact you from time to time to inform you of events we are hosting that you may find interesting.
Providing data is voluntary, you have the right to inspect, correct or request deletion of your data at any time. A request to delete data means withdrawal from any further engagement in QPTech’s recruitment processes and will result in the immediate deletion of your data. If you do not agree, please do not click the “Apply Now” button.
Attractive rate on offer