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Argus Technical Services · 1 day ago

Validation Engineer

Port Washington, WI

Full-time

Onsite

Entry Level

$50K/yr - $60K/yr

1+ years exp

Argus Technical Services is seeking a Validation Engineer to ensure compliance with FDA and company regulatory requirements. The role involves developing and executing protocols for equipment and processes used in manufacturing regulated products.

ConsultingInformation Technology

Responsibilities

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

Qualification

Equipment validationRegulatory complianceTechnical writingMicrosoft OfficeProject managementMechanical aptitudeCommunication skillsConfidentiality

Required

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