At a Glance
- Tasks: Lead cleaning process development and ensure compliance with industry standards.
- Company: Join Sekisui Diagnostics, a leader in innovative medical diagnostics.
- Benefits: Competitive pay, diverse workplace, and opportunities for professional growth.
- Other info: Be part of a dynamic team focused on innovation and excellence.
- Why this job: Make a real difference in healthcare by ensuring product quality and safety.
- Qualifications: Experience in GMP environments and cleaning verification processes required.
The predicted salary is between 37000 - 45000 £ per year.
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
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 focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. 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.
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.
Process Development Associate lV (Cleaning Specialist) employer: Sekisui Diagnostics GmbH
SEKISUI Diagnostics is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the heart of Maidstone. Employees benefit from comprehensive professional development opportunities, competitive compensation, and a commitment to maintaining a GMP-compliant environment, making it an ideal place for those seeking meaningful and rewarding careers in control systems engineering.
StudySmarter Expert Advice🤫
We think this is how you could land Process Development Associate lV (Cleaning Specialist)
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We think you need these skills to ace Process Development Associate lV (Cleaning Specialist)
Some tips for your application 🫡
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Sekisui Diagnostics GmbH that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
