SEKISUI Diagnostics
Process Development Assoc IV (Cleaning Specialist)
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Sekisui Diagnostics is looking for a Skilled Cleaning Specialist to join our
team in the Operations Department, Kent.
You:
As a Cleaning Specialist, you will be responsible for organising and conducting process development activities including planning, documentation, and training, in accordance with standard operating procedures. Evaluating cleaning performance across different equipment surface materials and product residue profiles to demonstrate cleaning process robustness and effectiveness
Responsibilities include:
- Work with cross functional team to define sampling strategies, acceptance criteria, and cleaning verification requirements
- Interact with the Analytical team and toxicologist to write, review and approve cleaning study protocols
- Execute laboratory cleaning studies using representative materials of construction (MOC) coupons
- Generate and interpret study data to support cleaning process development and verification activities
- Write cleaning assessment reports
- Support developing and optimising Clean-in-Place (CIP) and Clean-out-of-Place (COP) Cycles
- Creates and maintains cleaning-related SOPs to be in compliance with latest industry standards
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Skills / Pre-requisites:
You must have demonstrated experience in GMP manufacturing environments, including Cleaning Verification of equipment used in multi-product cleanroom areas, ensuring compliance with EU GMP Guidelines (EudraLex Volume 4)
Experience in designing and executing laboratory cleaning studies and developing Clean-in-Place (CIP) cycles and Clean-out-of-Place (COP) Cycles to support cleaning verification/validation activities
Who we are:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.
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Sekisui Diagnostics offers a competitive compensation and benefits package
Equal Opportunities:
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.
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