Senior Operations Technical Specialist

Senior Operations Technical Specialist
Southampton, Hampshire
 
About Us
 
We are Novacyt, a rapidly growing diagnostics group specialising in infectious diseases. We have a number of successful brands and serve a large global customer base, from hospitals to large corporates.
 
Our innovative offering enables healthcare providers to improve patient health and supports food manufacturers and we provide services to the healthcare, pharmaceutical and biotechnology industries.
 
We are now looking for a Senior Operations Technical Specialist to join us on a permanent, full time basis in Southampton.
 
The Benefits
 
- Competitive salary
- 25 days’ annual leave
- Ability to buy and sell annual leave
- Cycle to work scheme
- Refer a friend scheme
- Life assurance
- Private medical insurance
- Group pension scheme
 
This is an fantastic opportunity for a proven technical professional with a scientific background to advance their career with our leading company.
 
It is an exciting time to join our team as we are making huge leaps in the fight against COVID-19 and have recently been awarded a Breakthrough of the Year award at the European Mediscience Awards 2020.
 
We are the best in the world at what we do. If you are looking to learn, grow and succeed as part of a passionate team who are eager to make a difference, we want to hear from you.
 
The Role
 
As the Senior Operations Technical Specialist, you will be working within the Manufacturing Technical Department (MTD). The MTD team works very closely with the R&D, Quality Control and Manufacturing departments to support manufacture of newly developed and existing products. The role will have a particular focus on ensuring newly developed R&D products are able to transition into manufactured products and to resolve manufacturing problems.
 
This role requires scientific investigative skills, good knowledge of PCR and qPCR, excellent documentation skills and attention to detail, as well as experience in a laboratory and/or manufacturing environment. The Senior Operations Technical Specialist duties will include introducing new products into manufacturing through understanding data/evidence generated from R&D projects and translating the information into manufacturing and product documentation (SOPs, Supporting Technical Reports), product validation studies, lead in product failure investigations, as well as support and review investigations by the QC team.
 
There is a strong requirement for understanding and interpreting data, problem solving, root cause analysis, and fault finding within the products themselves and the manufacturing processes, with the aim to drive and lead improvements in the quality and production of products.
 
Specifically, you will:
 
- Design experimental studies
- Take responsibility for the execution and completion of experiments, including investigative experiments and product validation experiments
- Take responsibility for the execution and completion of study documentation (including technical summaries) in line with an ISO13485 quality management system as well as any other relevant regulatory standards e.g. CE IVD
- Lead in the data analysis and data interpretation
- Write and review SOPs and reports
- Lead in the resolution of manufacturing issues and technical problem solving
- Provide expert technical support for the manufacturing team
- Contribute to process improvements to drive manufacturing efficiency and accuracy
- Contribute to the development of alternative or novel methods to update pre-existing QC and manufacturing processes
- Use sage to build new products, track stock and for investigative purposes
- Participate in project and team meetings including presentation of progress reports on assigned projects
- Explore and advise on new manufacturing methods and raw material options
 
About You
 
To be considered as a Senior Operations Technical Specialist, you will need:
 
- Bachelor’s degree in a related field
- Experience of working within a laboratory and/or manufacturing environment
- Experience of working within a regulated environment, ideally working to ISO9001, ISO13485 and IVDR (in-vitro medical device regulations)
- Good scientific knowledge of PCR and qPCR
- Proven ability to apply scientific knowledge to problem solving
- Strong scientific investigative skills
- Strong data analysis and interpretation skills
- Problem solving ability
- Excellent report writing skills
- Accuracy and attention to detail
- Excellent interpersonal and communication skills
- Willingness to learn and challenge existing ideas and practices
 
Webrecruit and Novacyt are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.
 
So, if you are seeking an exciting new challenge as Senior Operations Technical Specialist, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.