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Validation Engineer

Absolute Recruitment

Newcastle Under Lyme

Permanent

ST53RE

Posted: 25/11/2022

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Working within the Quality Team, the Validation Engineer is accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations and IT Projects within a medical device and pharmaceutical (cGMP) environment.

Key duties will include:

* Prepare and issue Site Validation Master Plans (SVMP), Summary Reports and other documents for a validation exercise

* Organise and lead validation activities

* Plan validation activities, ensuring customer and business needs are met

* Provide validation leadership, ensuring all operations are carried out in compliance with regulatory and company requirements.

* Provide specialist knowledge on validations

* Promote effective working relationships ensuring they are maintained through the validation working party

* Support a continuous improvement culture within the business

* Provide leadership, guidance and direction to staff consistent with ISO13485, 21 CFR 820 and relevant pharmaceutical requirements

* Develop work plans, assign tasks and supervise teams to achieve validation requirements

* Ensure staff have knowledge and training require to carry out validation activities

* Maintain site validation status according to regulatory requirements

* Identify resource requirements and rate limiting steps within the SVMP

Key skills and experience required:

* Degree (or equivalent) within a science discipline preferred

* Previous Validation experience within medical devices or pharmaceutical is essential

* Proficient in Minitab or alternative software package is essential

* Excellent communication and people management skills

* Ability to work to deadlines, taking initiative within a controlled working environment

* Strong attention to detail

* Knowledge of Quality Management Systems would be beneficial

* Experience of manufacturing process validation would be an advantage

* ILM Level 5 would be beneficial

Hours of work: Monday – Friday, 35 hours between 7.45am and 5.15pm

Holidays: 25 days + bank holidays

Own transport required as you may be required to travel between sites

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