Validation Engineer

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
North West England
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
10/07/2019
Start Date:
ASAP
Recruiter:
VQ Life Sciences
Job Ref:
731701565

VQ Life Sciences are currently recruiting for a Permanent Validation Engineer based in the North West .

The right candidate needs to fully understand CSV, project life cycles, GAMP and have a general good breadth of knowledge and have minimum of 5 years full on experience in the Pharmaceutical environment. You will need to be able to work independently if required and will have accountability for all the work involved with and will be representing the company on site.

Responsibilities

The Validation Engineer will be responsible for ensuring that all manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements and GMP regulatory requirements.

Applicants must have the presence to promote the company image and ensure that this is enhanced by successful implementation of systems.

This will be an interesting and varied role, and the opportunity to progress within the team will be available to the right candidate. Appropriate training will be provided where required and in line with business requirements.

Applicants must have the ability to work on customers sites on their own. They will represent and enhance the company's image in related areas. They should be able to quickly gain the confidence of customers and internal staff. A can do positive attitude is required with the desire to extend their skill set, take on board new challenges and to help the company grow its reputation and customer base.

Ability to work as part of a team on a day to day basis to ensure that all projects are delivered on time, under budget, with the required quality that the companies clients expect and in line with the Company/Client Quality Management System. The successful candidate should have the ability to be able to work with minimal supervision on smaller projects or as part of a team on larger projects.

The successful candidate will be required to mentor junior members of staff and be actively involved in their development. The candidate will be expected to produce project documentation suite such as design documentation and test specifications and expected to review documents produced by junior engineers.

Essential Skills
* At least 5 years experience in Validation (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/Pharmaceutical (FDA/MHRA regulated industries).
* Strong cGMP, GAMP and GxP knowledge with knowledge of FDA 21 CFR Part 11, Annex 11 regulation.
* Must have strong ability to organise and manage multiple tasks in a fast-paced environment.
* Demonstrated understanding and hands-on experience generating and reviewing validation life cycle documents.
* Strong interpersonal skills, excellent review and analytical skills.
* Strong commitment to customer service and satisfaction are essential.
* Capable of building, cultivating and maintaining strong trusting client relationships.
* Strong written and verbal communication skills.
* Self-motivated and a quick learner of business processes and technologies.
* A working knowledge of or hands-on experience with Pharmaceutical, Biotech and Med Device production processes.
* Ability to discuss technical aspects of validation and GxP testing with clients.
* Strong attention to detail regarding documentation is a must.
* Must be well organised and capable of working effectively within a multi-disciplinary team.

If you're interested in this Permanent Validation Engineer position in the North West and have at least 5 years experience in Validation within the Biotech/Med Device/Pharmaceutical industries please get in touch. Or if you know anyone who might be interest please let them know.

Closing Date:
07/08/2019
Contact Details:
VQ Life Sciences
Contact: David Owen

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