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Equipment Validation Manager

Covance 7/12/2018 5:15:14 PM
JOB ID: 20003 Category: Scientific Advanced Degree
Harrogate, United Kingdom

   

 

Job Overview

Are you interested in making an impact through your everyday work? Are you passionate about advancing your career while making a difference in patients' lives? Do you love to lead and mentor teams, implement process improvements, and thrive in a dynamic, high-paced environment?

If you said yes to these questions and you are looking for a place where you can thrive and utilise your system validation skills whilst being challenged by working in a growing, global team, then consider working in the Equipment Management & Validation group. This is a permanent, full time position based at either the Harrogate or York site.

Working as part of the Global Laboratory Systems (GLS) group, you will lead and develop a team of Equipment Management experts focused on managing the equipment lifecycle through purchase, validation, maintenance and retirement, and leveraging the Global System Validation process to ensure systems are validated in a consistent and compliant manner, within the framework of Quality Risk Management principles. You will lead and develop a regional Equipment Management team to ensure that Client requirements and deliverables are met on time and on budget. You will also focus on developing the processes and structure of the wider Global Equipment Management group.

In this position, you will be responsible for:

* Driving Global best practices towards a singular process for all EM processes and documents.
* Serving as the subject matter expert and main point of contact for all equipment related needs including internal and external audits.
* Coordination with Lab Operations, Facilities Management, Chemistry Solutions Management, GMP QA and external vendors to determine and implement appropriate procedures and best practices for all equipment related needs.
* Acting as the Point of Contact for escalated Equipment issues.
* Managing the equipment lifecycle.
* Approval and review of equipment documentation.
* Coordination of in house or vendor maintenance and qualification activities:
* Supporting equipment projects (via system validation) for incoming work and lab expansion; prioritising and assigning resources.
* Initiation and management of GMP quality records related to equipment failures and system / process changes (CAPA, change management, deviations).
* Assisting Global Business Technology and other areas of Global Laboratory Systems to assist in computer system validation activities.
* Tracking and trending EM results and metrics (e.g., water testing, equipment performance metrics, work order completion, etc.).
* Managing the Chemistry Rees Responder program.
* Liaising with Finance and sourcing for CEP (Capital Expenditure Purchase) process.

What we're looking for in you:

You will have a strong equipment and system validation background and understand how to implement processes and procedures to ensure project and team success. You enjoy mentoring and providing strategic vision. Do these and the following statements sound like Experience that you can bring to Covance?

* GMP system validation Experience is required.
* A Bachelor's Degree or relevant equipment validation Experience in lieu of degree.
* The ability to get things done by influencing others (both internal and external).
* An up to date knowledge of regulatory guidelines is desirable.
* Ability to execute a strategy and vision with guidance from leadership.
* Ability to operate in ambiguous situations.
* Experience handling challenging client situations (conflict management).
* Strong coaching and mentoring skills to develop employees.
* Experience with processes improvement; facilitating root cause analysis and design of corrective/preventive actions.

Education / Qualifications

* No specific education requirements are required for this role.

* Technical certifications would be beneficial for this role.

Experience

* Experience in working in a GxP Quality Management System.
* Previous Experience managing an analytical laboratory equipment group.
* Proficiency in computing skills, including word processing and intermediate use of spreadsheets (e.g. Word, Excel).
* In-depth understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), system validation and an in-depth understanding of the GxPs.
* The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc


Position Type: Full-Time

Location: Harrogate, UK - United Kingdom



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).