Validation Engineer gea
-Client is specifically looking for candidates that work or have worked at Scientific Protein Labs sometimes referred to as (SPL) in Madison, WI https://www.splpharma.com/
- They are willing to provide a relocation bonus upon acceptance of an applicant willing to negotiate on a case by case scenario
The impact you will have:
• Execute and support validation and investigation activities
• Support the collection of validation-related data and perform respective data and statistical analysis
• Oversee and support process qualification, process validation and cleaning validation protocols and develop summary reports, including corresponding
periodic reviews
• Support process development activities in collaboration with other departments and other project teams
• Write technical protocols and reports and present results to diverse audiences of internal and external stakeholders
• Generate, update and approve standard operating procedures
• Manage and support change control, deviation and corrective and preventive actions development, out-of-specification and out-of-trend
laboratory investigations, approvals and implementations
• Create and maintain user and process requirements and risk assessments
• Support equipment qualifications and calibration activities, as necessary
• Participate in and report Engineering department performance outputs with bracketing and trending during management reviews and Current Good
Manufacturing Practices (cGMP) meetings
• Proactively propose and implement continuous improvements of quality systems and procedures
• Maintain compliance with ALI-PM’s policies and procedures
• As the workload demand changes for the department, additional responsibilities may be required
What we are looking for:
• Bachelor’s Degree in Engineering or related science field required
• Minimum two (2) years of experience with validation, qualification and engineering with U.S. Food Administration (FDA) and cGMP environments
required
• Experience drafting quality systems documentation and performing root cause analyses and investigations
• Experience working in a multi-functional team setting
• Advanced computer skills, including Outlook, Excel, Word and PowerPoint
• Strong verbal and written communication skills with the ability to establish collaborative working relationships
Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance
Schedule:
• 8 hour shift
• Day shift
• Monday to Friday
• Overtime
• Weekends as needed
Education:
• Bachelor's (Required)
Experience:
• FDA regulated facility: 2 years (Required)
• Validation/Engineering: 2 years (Required)
Ability to Relocate:
Relocate before starting work (Required)