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Senior Validation Specialist
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Senior Validation Specialist is an expert-level position in the Quality group reporting directly to the Validation Supervisor. You will manage your workload in accordance with the annual validation schedule, ensuring execution of work and completion of documentation to stringent timeframes, in order to achieve key business metrics. The role will also require active participation in site projects and multi-disciplinary teams, as well as direct liaison with customers to assess and implement their validation requirements. The post- holder will be the Subject Matter Expert for the site for all aspects of Validation, including process, equipment, cleaning, systems, and analytical method validation (existing, new or proposed)
- Essential: Bachelors degree preferably in one of the chemical or biological sciences, or in pharmaceutical engineering
- Desirable: Six Sigma/Lean Manufacturing qualification
- Minimum five years practical experience of a similar role within a GMP environment is essential, complimented with basic project management knowledge
- Working knowledge of ISO9001:2015, IPEC, EU Guidance on Good Manufacturing Practice (Orange Guide), EP/USP, aseptic processing, computer-system validation, and sterilisation systems
- Must be able to apply a risk-based approach to operation and interpretation of resulting data
- Knowledge of cell culture products and their applications is desirable but not essential
- Excellent organisational, verbal and written communication skills, with ability to manage and prioritise own workload and work to deadlines
- Report writing skills
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html