A Validation Engineer is required to support an in-vitro Diagnostic Assay manufacturer based in Dundee Scotland. The successful individual will be required to revise existing approaches to Equipment and Process Validations to meet the requirements of Abbott Rapid Diagnostics Global Quality Policies and Procedures.
Please note this is a contract role (until 31 December 2020).
The primary responsibilities of this role are to re-develop and document the site’s approach to both Equipment and Process Validation to be consistent with both Abbott Rapid Diagnostics Global Quality Policy/Procedure and accepted industry practices. This is to be performed in accordance with a pre-defined project timeline.
Perform a gap analysis between site’s Validation procedures and Global Quality Policy/Procedures. Based upon output, create and document future state which will meet the requirements of the Quality Systems Remediation Program. This is to include use of statistical rationales to support validation planning and acceptance.
Provide training and guidance regarding the revised process to end–users.
Catalogue and review all Equipment and Process Validations on the Dundee site to identify required remediation/revalidation using a risk based approach.
Design, document and execute any required remediation/revalidation.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility.
Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
Carries out duties in compliance with established business policies
Other duties as assigned, according to the changing needs of the business
Preferred educational background:
HND or BSc in technical field or equivalent.
Preferred experiential background:
Five to eight years of calibration-related experience.
- Five to eight years of calibration-related experience.
- Knowledge of basic cGMP calibration requirements preferably in vitro diagnostics.
- Experience with 21 CFR 820, ISO 13485.
- Strong working knowledge of instrumentation and control systems
- Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
- Must be detail-orientated, self-motivated and available for flexible scheduling.
- Strong communication, problem solving and motivational skills.
- Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with minimal supervision.
- Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.
- Strong proficiency in using MS Office, WORD, Excel, Visio and other data systems
- Excellent written and verbal communication skills
- Able to handle multiple tasks and must present exceptional prioritizing and organization skills.