Job Description

PM Group is seeking a Validation Engineer to join a client Cambridge.

Scope of Work :

* Leading assigned validation projects, ensuring complaint and timely performance in line with GMP requirements, industry standards (e.g. GAMP5, good documentation practice, data integrity), industry, process validation: General Principles and Practices), company procedures and business requirements, including the following activities:

* Definition in collaboration with key stakeholders of the validation strategy following a risk-based approach and ensuring regulatory and GMP requirements are met.

* Preparation of validation plans and protocols in line with defined and approved validation strategy and company templates, coordinating the review and approval by the required stakeholders and insurance through the company’s document management system.

* Management of validation non-conformances and resolution of issues with key stakeholders, including vendors, engineering department, production and/or liaising with quality assurance and/or the qualified person as appropriate.

* Input into the user requirements specification (URS) and co-oversight of factory and site acceptance testing (FAT/SAT) as required.

* Providing validation support of the execution of installation qualification (IQ), computer system validation (CSV), operational qualification (OQ), performance qualification (PQ) and process validation (PV) as defined in the respective validation protocol,. In close collaboration with engineering, production, and quality control departments.

* Interpretation and reporting of validation analytical and process data, writing up of validation reports for each stage of the validation cycle, coordinating the review and approval by the required stakeholders and insurance through the company’s document management system, ensuring documentation is completed and compliant with data integrity requirements.

* Liaising with quality assurance to provide the necessary validation documentation to support batch certification by the qualified person for release to market.

* Supporting change control activities, including performing validation impact assessments of changes, as required.

* Leading or supporting risk assessments (e.g, FMEA) and the identification of risk control measures as appropriate.

* Leading or contributing to the definition of control strategy for new or existing equipment and/or processes, in close collaboration with the engineering, production and quality assurance.

* Completing on-time all assigned quality system commitments (including change control actions, CAPA, training, document periodic reviews.

Requirements:

* Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sector

* Extensive validation experience

* Good understanding of the validation lifecycles

* Execution of qualification and validation activities

* Basic understanding of risk assessment principles

* Component in generation and review of technical documentation

* Successful candidates will be able to demonstrate technical competence, will be able to work efficiently and safely, and will be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable.

Outside IR35

Onsite

6-12 months