We currently have a requirement for 2 individuals to be recruited and developed into Computerised Systems Validation Engineers (CSV) within our Data Integrity team. The purpose of this role is to provide CSV support to business systems projects, ensure the completion of the quality, regulatory and technical approach set by Bespak, and to develop into and SME for CSV.
Participants recruited into this role will be developed under a specific development programme intended to educate the individuals in the following subject areas:
- Quality Systems, Data Integrity and applicable Regulations/Standards
- Computer systems validation and risk management.
- Validation Methodologies for computer systems.
- Defining and ensuring robust systems design and testing.
- GxP Computer systems management and control
- Leadership and Management tools, working in groups on complex systems
- Working with the line manager to ensure their completion of the CSV training program at the agreed stages.
- To deliver of all applicable validation deliverables to time, cost and quality standards to ensure good performance in assigned work
- To author, review and approve validation and risk assessments documents to ensure compliance under guidance or once pre-requisite training stages have been completed.
- Work with internal and external customers to ensure that their quality and regulatory requirements are being met.
Accountabilities will increase throughout the development period as progress and competence proven.
ESSENTIAL KEY ATTRIBUTES:
- Educated to degree level in science/engineering subject or equivalent experience.
- Experience in Process, Labs or IT Validation and Risk Management Process.
- Excellent communication (with all levels of the company, internal and external) and inter-personal skills, to enable the job holder to motivate colleagues, support other areas and influence at a senior level.
- Basic understanding of medical device or pharmaceutical regulations
- Strong experience in one of the following (Laboratories, Process Engineering or Quality Engineering)
DESIRABLE KEY ATTRIBUTES:
- Audit experience. (Preferably to ISO 13485 or Pharmaceutical QMS).
- Experience in software development, process automation or related software field
Please send your full application to Careers@Bespak.com