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.
REQUIRED QUALIFICATIONS:
Education:
- Must be enrolled at College or University in a science or engineering program.
Experience:
- No previous experience required.
Knowledge, Skills, Abilities:
- Well organized with the ability to follow directions and procedures.
- Robust 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.