Validation Engineer
3 hours ago
$50- $60K
1st Shift
Port Washington, WI
Job Category: Engineering
Job Details:
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.
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.
What you will do:
- 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 (Wis).
- 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.
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