Validation Engineer

Description:

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Cleaning Validation Engineer who is responsible for coordinating all cleaning validation and verification activities related to Drug Substance and Drug Product manufacturing, while providing adequate customer service. This person works in close collaboration with other groups such as Operations, Quality, Product Development, Engineering, and Project Management. As an expert for the validation of cleaning processes, you are responsible for the definition and application of cleaning strategy applicable for all products/equipment of the site. This role will also support other activities, related to current operations and customers.

The Role

 

• Be the site SME for the validation of cleaning process;
• Ensure that all validations are performed according to the regulatory, site and customer requirements;
• Integrating the production needs and ways of working in the cleaning strategy;
• Good understanding of the production (cGMP) process;
• Being an interface between analytical development and production + follow-up of activities on the shopfloor;
• Communication across all departments on the cleaning strategy implementation;
• Ensure that all activities are performed in time and with due quality;
• Author validation and procedure documentation including, but not limited to Cleaning Validation protocols, reports, and discrepancies;
• Investigate deviations as per need and execute corrections and/or develop preventive actions;
• Define and execute improvement projects and initiatives to improve cleaning validation strategy and customer/site support;
• Participate in customer and regulatory audits;
• Can be involved in other process engineering activities;
• All other duties as assigned
  
   

The Candidate

 

• Bachelor’s degree required. Preferably in an Engineering or Scientific discipline. Master’s degree preferred;
• Minimum three (3) years of experience in the Pharma, Medical Device or any GMP regulated environment required or an equivalent combination of education, training and experience in any GMP environment required;
• Minimum of two (2) years’ experience in Cleaning Validation required or equivalent combination of education, training and experience required;
• QbD experience preferred;
• Excellent oral and written communication skills.
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;