BlueBolt Recruitment

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Senior Pharmaceutical Facilties Engineer

South Wales - Salary circa £50,000

A pharmaceutical manufacturer in South Wales is seeking a Facilities Engineer.

Main Purpose of Job:

To work with all suppliers of new equipment and utilities for new investment in contained operations, ensuring successful FAT, Validation and Commercial Launch. An integral part of the new manufacturing facility start-up team. This position will initially report to the facility start-up manager and then will transfer to manufacturing operations once validation is complete for routine production.

Qualifications, Skills and Experience Required:

1. Mechanical/Electrical Engineering degree plus additional post graduate experience.
2. Knowledge of cGMP in contained operations (potent production or sterile products).
3. Regulatory validation knowledge for EU, US and Japanese markets including GAMP5 and 21 CFR11 compliance.
4. Ideally ISPE best practice experience with potent molecules and knowledge of SMEPAC testing.

Key Responsibilities:

1. To manage the maintenance and utility costs to the annual budget targets.
2. To optimise the facility and equipment uptime to achieve the annual OEE targets.
3. To ensure that the site complies with all effluent discharge licences.
4. To ensure a ‘vertical start-up’ of the new manufacturing facility and to achieve all safety, quality, delivery and costs targets (SQDC).
5. To oversee Engineering Operations for the existing Dedicated Containment Facility and to achieve all SQDC targets.
6. To establish a clear PPM Programme with Operational staff engaged in TPM activity.
7. To ensure safe interventions into all contained Operations and carry out/oversee annual facility re-validation, calibration and maintenance programmes as required.
8. To recommend annual capital Investments looking out over a 3 year horizon.
9. To maintain all electronic systems and comply with all existing regulatory licences.
10. To comply with company policies including internal and external Health and Safety and Environmental standards as required.
11. To identify self-development needs for future performance and link with best industry practice (eg ISPE).
12. To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

Key words: pharmaceutical project engineer, pharmaceutical facilities engineer, pharmaceutical plant engineer, gmp engineer, pharmaceutical site engineer, pharmaceutical engineering manager, pharmaceutical project manager, validation engineer, pharmaceutical mechanical engineer, pharmaceutical process engineer, pharmaceutical chemical engineer, pharmaceutical civil engineer, pharmaceutical maintenance engineer, south wales, Cardiff, Swansea

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