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: CQV Engineer – Student Internship – Commissioning Qualification and Validation

Wicklow, Leinster
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0110438 Date posted 11/03/2023 Location Wicklow, Leinster

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Job Description

JOB TITLE:       CQV Engineering Student (Commissioning, Qualification and Validation)

REPORTS TO:  Engineering Services Manager / CQV Engineer

JOB PURPOSE:

The intern will gain experience in the pharmaceutical manufacturing industry within the Engineering Services Group.

OBJECTIVES/PURPOSE

There is a requirement to hire a CQV Engineering Intern to join the Bray Site Engineering Services Department to support the current and future pipeline of CAPEX Projects including but not limited to:

  • Process and Packaging Equipment (OSD)
  • Facilities and Utilities
  • Computerized Systems and Automation Packages
  • Manufacturing and Packaging Processes
  • Cleaning
  • This position will support the commissioning, qualification and validation activities related to equipment, critical systems (utilities), facilities, computerized manufacturing systems, cleaning processes, as applicable.  
  • Primary tasks include development of protocols, commissioning, qualification/validation execution, preparing final reports and assembly of final validation packages.

ACCOUNTABILITIES / RESPONSIBILITIES

  • Preparation, review and approve documentation for cGMP / Validation of the following:
    - Equipment, Facility, Utility
    - Manufacturing Process
    - Cleaning
    - Computerized Systems and Automation Packages

- IT

  • Support Validation maintenance activities – Requalifications and Periodic Reviews – Equipment, Facilities and Utilities  
  • Supports projects that require team participation.  Must demonstrate competent and effective coordination, and organizational skills. 
  • Handles routine tasks with attention to detail, within required timelines.
  • Strong Technical writing abilities to support the preparation and review of Validation documentation (Risk Assessments, IQ, OQ, GMPAs, IOQRs etc)
  • Participate and interface with cross-functional project team members (Engineering, Production, Packaging, Regulatory Affairs, Quality Compliance, Quality Services, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation.  Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards. 
  • Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements – use of the KNEAT Paperless Validation system.
  • Evaluate quality standard of service providers for cGMP, including Validation requirements (Vendor qualification documentation).
  • Ensure up-to-date regulatory requirements for all validated operations, equipment and facility and utility packages.
  • 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.  May assist in closing compliance gaps as they are identified. 
  • Participate, as required, 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, where the cGMP’s and Quality are an integral part of the overall business.

EDUCATIONAL REQUIREMENTS:  

  • Studying towards third Level Qualification in Engineering or Science. 

RELEVANT EXPERIENCE:

  • Knowledge of the pharmaceutical industry would be preferable but not essential. 
  • Interest in pursuing a career in Commissioning, Qualification and Validation desirable

SKILLS/COMPETENCIES:

  • A self-starter with initiative, good interpersonal skills and a strong technical engineering  foundation  
  • The applicant should also have excellent communication, report writing, time management skills, and be highly IT proficient;  
  • Attention to detail is also required to comply with the relevant industry and Company quality standards and the cGMP rules pertaining to production. 

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time
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Patient


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People


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About our location

Wicklow, Leinster


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