Validation Engineer

Validation Engineer

Skills/Knowledge:

- Essential: 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.
- Attributes/Characteristics: Must be able to lead and give direction to Validation Projects and Teams.
- The individual must also be an active team member in Validation activities.

Role Purpose:

To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensure that all compliance issues and requirements of LifeScan Validation Policies and Procedures are addressed.

Responsibilities:

- Autonomy
- Self - manages day to day activities
- Seeks direction from the Validation Team Leader when required
- 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
- Independently prioritises work to meet deadlines
- Impact on Systems & Practices
- Suggest and sometimes may implement innovation and continuous improvement within the
- Validation process
- Delivery of Results/Customer Value
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Team Contribution
- Facilitates successful team behaviour within Quality Systems and across functional areas
- Relationship Skills
- Manages relationships externally and internally.
- Builds cross functional and cross-departmental support, fostering overall effectiveness
- Developing Others
- Holds self-accountable for measurable results.
- Creating the Environment
- Fosters harmony within Quality Systems.
- Promotes the value of diverse perspectives.
- Influences and persuades so as to bring about technical and process improvements.
- To ensure accuracy and maintenance of the Scotland Validation Master List.
- To review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
- To ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
- To ensure that all validation activities are carried out and reported in a timely MANNER.