Associate- Validation

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
• Assists with development of validation protocols and manage Regulatory queries and responses.
• Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
• Work effectively as a member of the Quality Operations (QO) Good Manufacturing Practices {also cGMP} training team as well as directly with Business Area Training Leads / Coordinators and SMEs within Quality to support Good Manufacturing Practices {also cGMP} and site training initiatives.
• Report to the Validation Section Manager, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.
• Work on summarization of data into concise reports that is reviewed by the QO product professional and approved by production and quality management.
• Define problems, collect data, establish facts, and draw valid conclusion.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

• Bachelor’s or Master Degree with minimum 3 year experience in injectable background
• Should have sound knowledge on Equipment qualification
• Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
• Excellent organizational skills, and ability to handle changing deadlines
• Strong communication with written and verbal skills
• Working knowledge of Microsoft Office, especially Excel for evaluation of data

• Technical writing experience
• Pharmaceutical Industry with laboratory process validation experience
• Working knowledge of equipment qualification and calibration specifically for laboratory equipment

Work Location Assignment: On Premise