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Job Description

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

Global Reporting

Level (CEO=1):

Line Manager’s Job/Position Title:

Site Engineering Services Lead

OBJECTIVES/PURPOSE (3-4 bullets)

There is a requirement to hire a Validation Technican to join the Bray Site Engineering Services Department to support the site Validation Maintenance activities (Requalification’s + 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.  

SCOPE

Financial:

Est. annual revenue range of accountability*:

TBD

Est. annual budget of responsibility:                                          

TBD

Leadership/People:

No. of direct reports: 0

No. of indirect reports: xx + ext. partners   0

Geographic Scope:

Ireland – Bray

*if applicable

ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

• 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, timely and accurately. 
• Strong Technical writing abilities to support the preparation and review of Validation documentation (Risk Assessments, IQ, OQ, GMPAs, IOQRs etc)
• Initiatian and management of 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) 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.
• Evaluate quality standard 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.  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.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Must have basic experience in validation disciplines

• Process and Packaging Equipment (OSD)
• Facilities and Utilities
• Computerized Systems and Automation Packages
• Manufacturing and Packaging Processes
• Cleaning
• IT and Security

• Excellent technical writing and verbal communication skills. 

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience. 
• Ability to design and influence in own area of expertise. 

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)

• Must demonstrate effectiveness in task completion, decision-making, exception management, training, and problem solving. 

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

• Must be able to work with site and global SMEs from  Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

• Must be able to use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of validation methodologies and principles to perform validation on a variety of systems. The successful candidate will support the co-ordination of site validation activities as per current global and Site Validation Master Plan Lifecycle and internal Quality Management systems.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• Ability to make sound decisions and manage priorities in alignment with site drivers. 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:   (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

• Bachelor’s degree preferably in Engineering or Science; and other job related experience. 
• Strong attention to detail and accuracy.
• Strong interpersonal skills to support relationships with a number of stakeholders
• Familiarity with the CQV Lifecycle:  validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantage
• Familarity with Quality Risk Management activities (FMEA’s etc).
• Strong IT and computer skills – role will include use of mutiple documentation management systems (Veeva, KNEAT, TW)

Date: 02-Nov-2023                                            Completed by: Darren Rabbitt

                                                                            Site Engineering Services Lead

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