Validation Engineer bmj - $ 80k + based on experience Direct Hire
: Job Details :

Validation Engineer bmj 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 scenarioThe 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 correspondingperiodic 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-trendlaboratory 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 GoodManufacturing 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 requiredWhat 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 environmentsrequired• 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 relationshipsBenefits: • 401(k)• 401(k) matching• Dental insurance• Employee assistance program• Health insurance• Life insurance• Paid time off• Parental leave• Referral program• Vision insuranceSchedule: • 8 hour shift• Day shift• Monday to Friday• Overtime• Weekends as neededEducation: • Bachelor's (Required)Experience: • FDA regulated facility: 2 years (Required)• Validation/Engineering: 2 years (Required)Ability to Relocate: Relocate before starting work (Required)