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Description

Pay Rate: XXX

Quality Assurance, Computer Systems Validation Engineer II

When you join us at Client Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of XXX billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The role is responsible for Computer Systems Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

How will you make an impact?

The CSV Validation Engineer will be responsible for oversight of all GMP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.

This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.

What will you do?

• Perform GMP computerized system validation projects in compliance with GMP, 21 CFR Part 11, Annex 11 and Data Integrity.
• Ensure that GMP systems meet intended uses and comply with applicable regulations, current industry practices, and Client Scientific policies and procedures. Validation projects may include manufacturing systems, lab systems, and steady state activities around these applications.
• Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
• Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
• Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
• Coordinate and provide training and/or opportunities for career development of others.
• Perform other duties as assigned.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.

How will you get here?

Education

• Bachelor s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

• Minimum of 2-4 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of one (1) year direct CSV validation experience.
• Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GMP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
• Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment.
• Solid Knowledge of validation of cGMP automation/computerized systems is preferred within an EMA/FDA regulated environment.
• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
• Experience with system validation across GMP landscapes, specifically GMP applications.
• Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.
• Experience with the qualification of single use technology is desired.

Knowledge, Skills, Abilities (Required)

• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry
• Excellent communication and listening skills
• Ability to build and maintain strong collaborative relationships across multiple departments
• Microsoft Office and database management skills
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Knowledge, Skills, Abilities (Preferred)

• Experience with biological manufacturing processes.
• Project Management advanced experience.
• Certified Lean Professional or Six Sigma