Bespak, a Consort Medical Company, is a global market leader in the manufacture of drug delivery devices for pharmaceutical partner Companies, including respiratory, nasal, and injectables products. Bespak have contributed to some of the world’s leading medical devices.
We currently have a requirement for an individual to be recruited and developed into an Computerised Systems Validation Engineer (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.
The participant 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
We strive to be an ‘Employer of Choice’ and, in addition to our intrinsic benefits and career and development opportunities, we offer an attractive range of employee benefits, including our Group Personal Pension Plan, Healthcare Scheme, Permanent Health Insurance, an all-employee share incentive scheme, Save as you Earn (SAYE) Scheme and 28 days (plus 8 days Bank Holiday) paid annual leave.
If this sounds like the ideal role for you then we’d love to hear from you. Please apply to Careers@Bespak.com and send us your CV for review.