CSV Engineer I / II

CSV Engineer I / II

Location: Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate Job category: Engineering Target start date: 6/10/2024 Work Location: On-Site Shift: 1st

uni

Qure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uni

Qure is directly or indirectly responsible to improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.

The Role

The incumbent is responsible for assisting the Validation Manager in completion of all project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, uni

Qure quality management system and current industry practices.(includes standard operating procedures, technical reports and risk assessments).

Key Responsibilities:

The candidate's responsibilities will include, but are not limited to:

• Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.

• Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.

• Investigates / troubleshoots validation problems.

• Support and/or initiate investigations into protocol non-conformances and site deviations.

• Serve as initiator and owner of validation related change controls and corrective and preventative actions.

• Provides input to standard operating procedures related to validation practices.

• Support the implementation of validation programs (e.g., CSA/CSV, Data Integrity).

• Represent the validation department at team meetings or projects.

• Performs periodic reviews and ongoing support of validated systems post Go-Live.

• Perform revalidation and change control validation related activities.

• Ability to apply complex system validation principles to work assignments.

• Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, CMS, and other automation upgrades.

• Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.

• Assist validation activities of cross functional teams that include technical functions in all GxP areas such as Quality Control, Information Systems, Manufacturing and QA Engineering.

Qualifications

Individuals proposed for this work must have the following attributes:

• A minimum of a Bachelor's degree in Engineering in related field with 3 to 5 years of computer system validation experience or Master's Degree in related field with 2 to 4 years of computer system validation experience.

• Strong communication skills (written and verbal)

• Strong working knowledge on Microsoft Office suite

• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization

• Ability to manage multiple activities

• Attend meetings where required and provide subject matter expertise as applicable on the specifics of the deliverables.

Core competencies

• The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels from uni

Qure and other contract firms.

• The ability to report on project activity in a clear and concise manner.

• The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.

• The ability to listen and respect fellow project team member's ideas and opinions and work through conflict and disagreements.

• GMP compliance knowledge including knowledge of 21 CFR Part 11, 210, 211, and 820 requirements, Annex 11, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5.

• Experience in thorough testing of applications, computerized systems, changes and implementations.

• Excellent written and oral communication to include accurate and legible documentation skills.

• Ability to work in a fast-paced environment.

• Independent work skills and a strong work ethic.

• Must be able to sit or stand for prolonged periods of time.

• Must be able to travel between local uni

Qure facilities.

• Good knowledge and skills in Automation systems and process (critical monitoring system)