Job Description / Role Profile Job/Position: CQV Engineer – Student Internship – Commissioning Qualification and Validation
BU/Organization: GMS / Small Molecule
Department: Engineering Services
Location: Bray
Management Level: TET 7
Line Manager's Job/Position Title: Site Engineering Services Lead
OBJECTIVES/PURPOSESupport site Validation Maintenance activities (Requalifications + Periodic Review Processes).Support all validation activities related to current and future pipeline of CAPEX and Continuous improvement projects.Qualify equipment, critical systems, facilities, computerized manufacturing systems, cleaning processes, and sterilization processes.Develop protocols, coordinate validation activities, execute qualification/validation, prepare final reports, and assemble final validation packages.ACCOUNTABILITIESPreparation, review, and approval of documentation for cGMP / Validation of Equipment, Facility, Utility, Manufacturing Process, Cleaning, and Computerized Systems.Support Validation maintenance activities – Requalifications and Periodic Reviews.Demonstrate competent and effective coordination and organizational skills.Handle routine tasks with attention to detail, timely and accurately.Strong Technical writing abilities to support preparation and review of Validation documentation.Initiate and manage change control records.Participate and interface with cross-functional project team members to determine validation strategy.Write protocols and reports, execute, interpret, and evaluate validation documents.Ensure up-to-date regulatory requirements for all validated operations.Utilize Quality-Engineering tools for problem-solving and assist in risk analysis.Identify gaps related to validation requirements and assist in closing compliance gaps.Participate in the investigation and closure of non-conformances/events.Perform other duties as directed by supervisor.Foster an ethos and culture of cGMP & Quality awareness.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Bachelor's degree preferably in Engineering or Science.Strong attention to detail and accuracy.Strong interpersonal skills to support relationships with stakeholders.Familiarity with the CQV Lifecycle is an advantage.Familiarity with Quality Risk Management activities.Strong IT and computer skills.Date: 02-Nov-2023 Completed by: Darren Rabbitt
Site Engineering Services Lead
LocationsBray, Ireland
Worker TypeEmployee
Worker Sub-TypePaid Intern (Fixed Term) (Trainee)
Time TypeFull time
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