The Validation Engineer has the primary responsibility to provide documented evidence through the developments and execution of protocols, the equipment, and processes used to manufacture regulated products, to meet all the FDA and regulatory requirements
We are looking for a candidate with 1-2 years of experience with packaging, equipment validation, or engineering technical writing. Requires an associate or bachelor’s degree with a strong emphasis in a natural science or engineering. Candidates must have mechanical aptitude and experience in a regulated industry is preferable. The ideal candidate will be an independent worker, self starter, detailed, and have demonstrated the ability to see and understand a process.
Essential Functions
- Communicate technical knowledge with peers and colleagues in other departments.
- Develop and execute installation, operation, and performance qualification protocols and summary reports for processing equipment, utilities, computerized systems, and laboratory equipment.
- Develop and execute product validation protocols.
- Develop and execute cleaning validations.
- Perform training.
- Write Standard Operating Procedures (SOP’s) / Work Instructions..
- Interface with customers.
- Must maintain good documentation practices.
- Communicate effectively with cross-functional groups to meet compliance requirements and release goals.
- Assist in the maintenance of the Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP) schedules throughout the organization.
- Other duties as assigned by management.
Requirements
- Requires an associate or bachelor’s degree with a strong emphasis in a natural science or engineering.
- Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
- Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
- Strong project management skills.
- Familiar with regulatory and GMP requirements for pharmaceutical manufacturing operations.
- PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint) along with Google Suite and Microsoft Outlook, statistical analysis software, and contract management software.
- Proven ability to maintain confidentiality and discretion with information.
