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

Company: ARGUS TECHNICAL SERVICES
Location: Madison
Posted on: November 1, 2024

Job Description:

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 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)

Keywords: ARGUS TECHNICAL SERVICES, Fond du Lac , Validation Engineer bmj - $ 80k + based on experience Direct Hire, Engineering , Madison, Wisconsin