Validation Technician - UK
Corin, United Kingdom
Job Description
Corin is seeking a Validation Technician to ensure compliance of equipment and process validation with applicable standards relating to the validation of medical devices (21 CFR 820.75, ISO 13485, ASTM, GAMP 5) within pre-agreed timelines.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The key responsibilities of the Validation Technician are to:
- Validate equipment used in the manufacture, cleaning and packing of medical devices to the required regulatory standards (e.g. robotic polishing, packing machines, multi-axis cutting machines).
- Write and execute validation protocols (Installation Qualification, Operational Qualification, Performance Qualification, Process Validation), including hands-on testing.
- Co-ordinate cleaning validation laboratory testing, cleaning monitoring and cleaning validation technical report writing.
- Statistical analyse attribute and continuous data sets. Produce control charts and capability reports.
- Work to Good Manufacturing Practice (GMP) requirements and following industry best practice.
- Communicate progress at team meetings and chair meetings for key validation projects.
- Support corrective amp; preventive action projects.
- Write standard operating procedures and work instructions.
- Report on status of ongoing projects.
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820
- Ensure that process and timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOPs) and in support of Corin’s Global Objectives for CAPA
Requirements
The ideal Validation Technician will have / be:
- BSc in biological or chemistry based subject preferred.
- Practical experience within Medical Device or Pharmaceutical industry preferred; experience within manufacturing environment beneficial.
- Strong understanding of computer systems and statistics.
- Strong analytical and problem-solving skills.
- Effective writing and verbal communication skills.
- The ability to work independently with minimum supervision, to work within multi-disciplinary teams and multi-task.
Benefits
You will receive a competitive salary and annual bonus as well as;
- 25 days holiday plus bank holidays.
- Excellent pension up to 9.7% provided by Corin when you contribute 4%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment
Corin is an equal opportunity employer. Qualified applicants are considered without regard to age, gender, race, creed, colour, national origin, ancestry, marital status, sexual orientation, gender identity, disability, veteran status.