Description
Validation Engineer/Limerick, Ireland/12 Months Contract/40 to 49 EUR (Per Hour)
Position Description and Responsibilities
- 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. Primary Tasks and Responsibilities
- 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.
- 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.
Non Technical Skills and Additional Details
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
Technical Profile Requirements
Knowledge of bespoke validation. Process knowledge and documentation.
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.
Must be able to lead and give direction to Validation Projects and Teams.
Experience in regulated environment which has been spent carrying out validation and/or testing activities.
A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
Experience in a regulated industry
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.