Job/Position: CQV Engineer – Student Internship – Commissioning Qualification and Validation
BU/Organization: GMS / Small Molecule
Location: Bray
Line Manager’s Job/Position Title: Site Engineering Services Lead
There is a requirement to hire a Validation Technician to join the Bray Site Engineering Services Department to support the site Validation Maintenance activities (Requalifications + Periodic Review Processes) along with supporting all validation activities related to the current and future pipeline of CAPEX and Continuous improvement projects including but not limited to:
* Process and Packaging Equipment (OSD)
* Facilities and Utilities
* Computerized Systems and Automation Packages
* Manufacturing and Packaging Processes
* Cleaning
* IT and Security
This position is responsible for qualifying equipment, critical systems (utilities), facilities, computerized manufacturing systems, cleaning processes and sterilization processes, as applicable.
Primary tasks include development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans.
Responsibilities:
* Preparation, review and approve documentation for cGMP / Validation of the following:
- Equipment, Facility, Utility
- Manufacturing Process
- Cleaning
- Computerized Systems and Automation Packages
* Support Validation maintenance activities – Requalifications and Periodic Reviews – Equipment, Facilities and Utilities
* Support projects that require team participation, demonstrating competent and effective coordination, and organizational skills.
* Handle routine tasks with attention to detail, timely and accurately.
* Strong Technical writing abilities to support the preparation and review of Validation documentation (Risk Assessments, IQ, OQ, GMPAs, IOQRs etc).
* Initiate and manage change control records.
* Participate and interface with cross-functional project team members (Engineering, Production, Packaging, Regulatory Affairs, Quality Compliance, Quality Services, Supply Chain, and other technical disciplines) to determine validation strategy and system validation requirements based on concepts of life cycle.
* Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements.
* Evaluate quality standards of service providers for cGMP, including Validation requirements (Vendor qualification documentation).
* Ensure up-to-date regulatory requirements for all validated operations.
* Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA).
* Identify gaps related to validation requirements and Global Validation procedures.
* Participate in the investigation and closure of non-conformances/events, corrective actions and preventative actions.
* Perform other duties as directed by supervisor.
* Work with management and staff to foster an ethos and culture of cGMP & Quality awareness.
Minimum Qualifications:
* Bachelor’s degree preferably in Engineering or Science; and other job-related experience.
* Must have basic experience in validation disciplines.
* Excellent technical writing and verbal communication skills.
* Strong attention to detail and accuracy.
* Strong interpersonal skills to support relationships with various stakeholders.
* Familiarity with the CQV Lifecycle and Quality Risk Management activities (FMEA’s etc.) is an advantage.
* Strong IT and computer skills – role will include use of multiple documentation management systems (Veeva, KNEAT, TW).
Date: 02-Nov-2023 Completed by: Darren Rabbitt
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