Biotechnology Life Sciences
Location York, Yorkshire.
Salary Up to £35,000.00
A contemporary opportunity for an individual with a competency for validating equipment and technical transfer has emerged within a rapidly expanding life sciences company based near to the historic city of York! The company seek to hire an individual who demonstrates their passion for the betterment of people’s lives.
As a validation engineer, you will be directly involved in managing the receipt and validation of all equipment on site and be critical in supporting the business’ growth by supporting the Tech Transfer and Operational teams. Primary duties include the preparation and issuing of Validation Master Plans, calibration activities, summary reports, projects regarding processes, facilities, equipment, cleaning, and CSV/IT, and providing of guidance and specialist engineering knowledge to staff in compliance with regulatory and company guidelines. You will also display exchangeable experience within equipment validation in a regulated environment, an understanding of ISO13485 and 21 CFR820 and a competency in working alongside auditors.
- Plan calibration activities for all existing equipment to satisfy the needs of the business and customers, cohering with the overall project aims.
- Organize and issue Validation Master Plans, Summary Reports, and other essential documentation for a validation exercise, providing the best possible service. Addressing site validation gaps, rate limiting steps and requirements for resources via Master Plans.
- Ensure all PPM activities are scheduled and completed.
- Manage projects relating to processes, facilities, equipment, cleaning, and CSV/IT Validation are compliant with regulatory and company requirements.
- Demonstrate specialist engineering knowledge on process, facility, equipment, cleaning and automation/IT issues to the staff adhering to ISO and other regulatory standards.
- Generate and solidify effective working relationships through the validation working party. Promoting a continuous improvement culture within the business.
You will have:
- Ideally you will hold a degree certification (or equivalent demonstrable experience) with experience in equipment/automation validation, analytical methods, computer system validation and equipment qualification within a regulated industry.
- Manufacturing process validation experience preferable, including the validation of new equipment and changes to established processes through the lifecycle approach to validation.
- Cleaning validation experience should include validation of cleaning processes on a wide variety of commercial manufacturing equipment.
- Excellent knowledge of ISO13485 and 21 CFR820 is essential with demonstrable experience in direct investigation/troubleshooting of equipment problems. Additional experience within reading/contributing to regulatory documents.
- Good statistical knowledge (DOE, capability studies, Gauge R&R, etc.).
- Experience interacting with auditors (internal and external) and supporting audits, followed with overseeing the closure of gaps identified during the audits.
The company offer a variety of benefits including 25 + 8 days holiday, company pension (6% company contribution after probationary period), cycle to work scheme, active wellbeing and events calendar, SAYE scheme 1 year after joining, subsided gym membership and an employee recognition scheme with the opportunity to be awarded £250 if nominated!
If this opportunity interests you, apply with your CV to [email protected]