Validation Engineer

On Target Recruitment Ltd; Birtley; On-site; GBP 45,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to ensure compliance with validation needs in the medical devices sector. This role involves validating production and software processes, creating validation plans, and supporting cross-functional teams. The ideal candidate will hold a degree in mechanical or electrical engineering and have experience in medical device manufacturing. Join a company known for its outstanding reputation and commitment to employee welfare, where your contributions will directly impact product quality and service excellence. If you're ready to make a difference in a dynamic environment, this opportunity is for you.

Benefits

Death in Service (2 x Salary)

Employer Pension (5% employer + 5% employee)

23 Days annual leave + bank holidays

Health Shield - Employee Health Cash Plan

Perkbox

Qualifications

• Erfahrung in der Herstellung von Medizinprodukten oder pharmazeutischen Produkten.
• Verständnis von Qualitätsmanagementsystemen für Medizinprodukte (EN ISO 13485).

Responsibilities

• Erstellung von Validierungsplänen und zugehörigen Protokollen.
• Unterstützung bei der Optimierung von Produktionsprozessen.

Skills

Kommunikationsfähigkeiten

Teamarbeit

Projektmanagement

Education

Bachelor in Maschinenbau

Bachelor in Elektrotechnik

Tools

MS Office

Job description

The Company:

UK manufacturer of single use medical devices.

Global reach.

Outstanding reputation for service and product quality.

Looks after their employees.

Benefits of the Validation Engineer:

£45k basic salary,
Death in Service (2 x Salary),
Employer Pension @ 5% employer + 5% employee,
23 Days annual leave + bank holidays,
Health Shield - Employee Health Cash Plan,
Perkbox.

The Role of the Validation Engineer:

Our client is a leading medical devices manufacturer.

This role is to ensure all site validation needs are met.

You will be responsible for validating all production, service provision, computer and software-based processes, the result of which cannot be verified by subsequent monitoring or measurement.

Validation must demonstrate the ability of these processes to consistently achieve expected results. The role includes re-validation of established processes as well as initial validation of amended or new processes, such as those introduced through new product development activities.

Responsibilities include:

1. Creating Validation Master Plans and associated protocols.
2. Create or amend standard operating procedures in accordance with the results of the validation.
3. Creating validation and related working forms.
4. Supporting site cross-functional technical writing needs.
5. Maintenance of Sterilisation Validation for both Gamma and Ethylene Oxide processes.
6. Assist in the implementation of the validation protocols and write the validation reports.
7. Support cross-functional risk management activities.
8. Support in the optimization of production processes.
9. Preparation of plans for maintenance, service, calibration, re-validation and cleaning of test and production equipment.
10. Policing and coordinating maintenance, service, calibration, re-validation and cleaning.
11. Advise the business on current best practice in validation and keep abreast of changes.
12. Contribute to continuous improvement projects.

The Ideal Person for the Validation Engineer:

Must hold a mechanical engineering or electrical engineering degree.
Must have previous experience of medical device or pharmaceutical manufacturing.
Must have practical experience in manufacturing technology and quality assurance.
Must have understanding of Quality Management Systems for medical Devices (EN ISO 13485, 21 CFR 820).
Experience in validation / qualification.
Experience in Project Work and/or Project Management.
Good to very good knowledge of common MS Office Programs.
Able to adhere to and communicate the company values.
Must have strong communication skills able to communicate with all levels of organisation.
A good team player who is able to adapt to working independently or with new or short-term teams.

If you think the role of Validation Engineer is for you, apply now!

Consultant: David Gray
Email: (url removed)
Tel no. (phone number removed)
Candidates must be eligible to work and live in the UK.

About On Target:

At On Target, we specialise in sales, technical and commercial jobs in the Engineering, Construction, Building Services, Medical & Scientific, and Commercial & Industrial Solutions sectors, enabling our consultants to become experts in their market sector. We place all levels of personnel, up to Director across the UK and internationally.