Posted

30+ days ago

Description

⦁ JobTitle:  
Validation Engineer - SeniorJ04566

⦁ About Company:
Our client based in Limerick is seeking a Validation Engineer Senior to join its expanding team.

⦁ Duration of Job:
12 months 

 Summary Objective:
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Johnson & Johnson Validation Policies and Procedures are addressed.


⦁ Job Duties:
• Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise
• Suggest and sometimes may implement innovation and continuous improvement within the Validation process Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
• Facilitates successful team behaviour within Quality Systems and across functional areas Manages relationships externally and internally.
• Builds cross functional and cross-departmental support, fostering overall effectiveness Fosters harmony within Quality Systems.
• Influences and persuades so as to bring about technical and process improvements.
• Ensure accuracy and maintenance of the Johnson & Johnson Validation Master List.
• Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
• Ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
• Ensure that all validation activities are carried out and reported in a timely manner.
• Ensure compliance through assisting in audits.
• Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Johnson & Johnson Policies and Procedures.
• Facilitates, encourage and coordinate continuous improvement with respect to validation activities.

• Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment.

• Lead by example, inculcating the Credo values in all actions within the workplace.





Requirements

• Requirements 

Technical Profile Requirements

• Knowledge of bespoke validation.

• Process knowledge and documentation.

Desirable:

• In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry

• High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.

• Working experience of validation computer systems for use in a FDA regulated environment.

 

Non-Technical Profile Requirements

• Must be able to lead and give direction to Validation Projects and Teams.

• Individual must also be an active team member in Validation activities


 

Methodology/Certification Requirements

Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base

• Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.

Desirable:

• A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience

• Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.



Benefits

Benefits

Benefits of working with Independent Solutions

  • Benefit from Independent Solutions ethical principles!
  • We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency
  • While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team
  • We offer attractive rates - competitive margins compared to our competitors.
  • Payment on time and in full
  • We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
  • We work for you !



• Requirements Technical Profile Requirements • Knowledge of bespoke validation. • Process knowledge and documentation. Desirable: • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. • Working experience of validation computer systems for use in a FDA regulated environment. Non-Technical Profile Requirements • Must be able to lead and give direction to Validation Projects and Teams. • Individual must also be an active team member in Validation activities Methodology/Certification Requirements • Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base • Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities. Desirable: • A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience • Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
Source: Independent Solutions