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Senior Validation Specialist

 

A career at our company is an ongoing journey of discovery: our 58,000 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 Role:

 

The Senior Validation Specialist is an expert-level position in the Quality group reporting directly to the Validation Supervisor.

Key responsibilities include:

 

  • Performs all validation activities relating to the Irvine site, routine and project-related
  • Generates validation protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements
  • Plans and coordinates execution of protocols
  • Collates and evaluates data from executed validation protocols and ensures summary reports are generated and approved
  • Generates or approves Quality Risk Assessment documents in relation to executed validation activities
  • Investigates, assesses and closes deviations related to closure of validation activities and raises CAPA’s as required
  • Actively participates in relevant change control activities and risk evaluation systems as they pertain to validation
  • Provides status updates and reports progress to the Validation Supervisor
  • Leads small multi-disciplinary teams as required
  • Supports implementation of the site Data Integrity roadmap
  • Interacts with customers to understand specific validation requirements, ensuring customer needs are met
  • Actively participates in internal, customer and regulatory audits as Subject Matter Ex[1]pert in site validation activities
  • Drives Continuous Improvement initiatives relating to overall quality of product, system improvements and regulatory expectations
  • Active participation in EHS, ensuring culture of safety and environmental awareness and managing completion of Risk Assessments relating to validation activities
  • Delivers GMP and related training programmes site-wide and externally where required
  • Participates in Capital Expenditure initiatives related to site improvements as validation SME

 

Who You Are:

 

  • Bachelors degree preferably in one of the chemical or biological sciences, or in pharmaceutical engineering
  • Six Sigma/Lean Manufacturing qualification desirable
  • Extensive 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
  • Computer literacy and procedure development
  • Working knowledge from a GMP environment with a high level of attention to detail
  • Excellent organisational, verbal and written communication skills, with ability to manage and prioritise own workload and work to deadlines
  • Report writing skills
  • Root Cause Analysis or similar analysis

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

 

Job Requisition ID:  230741
Location:  Irvine
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

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. 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

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.


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