Contract opportunity available for a Validation Engineer to be based in Hatfield for a client who specialise within the Pharmaceutical sector.
Location to be based in Hatfeild. Contract length is 12 Months +
Some additional benefits include: Free onsite parking, Dry cleaning facilities, on site shwoers and locker facilities, subsidised restuarant and coffee shop.
Validation Engineer Purpose
This job is responsible for the provision of validation and project support to the companies manufacturing and packaging operations located at the Hatfield European Knowledge Centre.
This includes the implementation, qualification and validation of processes and equipment used for the manufacture, packaging, testing, storage and distribution of marketed drug products to comply with current GMP, Corporate expectations and industry best practice.
General Responsibilities (Safety, Quality, Customer, Cost and Innovation)
Standard clauses for all employees:
To ensure that operations conducted are performed in accordance with the requirements of the companies Corporate Standards, GMP and GDP Guidelines and Industry Standards.
Duties are performed to ensure:
- A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
- The quality of products manufactured and released is assured through adherence to all procedures.
- Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
- All stakeholder and customer expectations are understood and met through communication.
Job Specific Responsibilities
Details of responsibilities:
- Lead commissioning, qualification and validation (CQV) activities within the manufacturing / packaging facilities at the Hatfield site.
- Develop qualification protocols for all new projects.
- Review and approval of vendor documentation to support on-site Good Documentation Practice (GDP) requirements.
- Support project leaders in the coordination of commissioning and qualification activities in line with the project schedules and operational requirements.
- Execute IQ / OQ protocols for site utility systems, HVAC, general facility, packaging and process equipment.
- Ensure that current Good Manufacturing Practices (cGMPs) and Good Engineering Practices (GEP) are applied in all areas of responsibility.
- Provide CQV support for production projects to ensure the completion of key project deliverables including vendor assessments, design reviews and factory acceptance testing.
- Support the generation and archiving of related project documentation including validation plans, test protocols and reports.
- Coordinate with quality department to ensure an acceptable resolution of outstanding CQV incidents, CAPA actions and deviations.
Skills and Competencies
- HNC / Degree level in engineering or an appropriate scientific discipline.
- Demonstrated experience within the pharmaceutical industry including commissioning, qualification and validation.
- Availability for EU travel for Factory Acceptance Testing of new equipment.
- Experience of document creation and execution at various stages of qualification in the validation lifecycle.
- An understanding of current EU GMP and US FDA regulatory requirements.
- Appreciation of GAMP5 and Computer Systems Validation including 21 CFR Part 11 and EU GMP Annex 11 compliance.
- Good leadership and interpersonal skills.
- Ability to work independently or part of a multi-disciplined team.
- Excellent oral and written communication.
- Attention to detail and an aptitude for neat, clear documentation.
If you are interested and would like to be put forward pelase apply through this advert immediately.