Validation Associate - Co-op Student

Job Summary

Responsible to support the creation and on time delivery of qualification protocols for cleaning validation, process validation and bulk hold studies according to CPL’s Validation Program and current GMP/cGMP requirements. Support with managing validation projects to support operational efficiency and customer needs. Support with managing validation activities in alignment with regulatory requirements and organizational objectives.

JOB RESPONSIBILITIES: 

• Develop and support with execution of process validation protocol, cleaning validation protocols, and bulk hold studies ensuring compliance with regulatory requirements and industry standards.
• Collaborate closely with cross-functional teams (such as Production Operations, Process
• Engineering, Maintenance, Quality, Account Management, and other relevant departments)
• teams to ensure prompt execution of validation studies.
• Compile results obtained from validation studies and generate comprehensive summary reports.
• Support with updates to Standard Operating Procedures (SOPs) pertinent to the Validation Program.
• Participate in continuous improvement initiatives to enhance validation processes and procedures. 
• Performs responsibilities in an efficient and timely manner. 
• Other duties as assigned.

• Must be enrolled at College or University in a science or engineering program.

• No previous experience required.

• Well organized with the ability to follow directions and procedures.
• Strong working knowledge and experience with Microsoft Office 365.
• Excellent verbal and written English communication skills.
• Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.

• Some flexibility in work schedule