Validation Engineer ajc

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Rare opportunity to relocate to Omaha, NE. They are willing to provide a relocation bonus upon acceptance of an applicant willing to negotiate on a case-by-case scenario

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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

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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)

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