Validation Engineer (f/m/d)

Excelitas Technologies Corp.; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Excelitas Technologies Corp. is seeking a qualified engineer to lead qualification and validation of production facilities and processes. You will define qualification strategies, conduct DoE studies, and collaborate with production, QA, development, and maintenance teams.

The role requires a technical degree, several years of qualification/validation experience, knowledge of Cp/Cpk, SPC, MSA, and DoE, and strong communication across sites in German and English.

Qualifikationen

• Bachelor’s or Master’s degree in a technical field such as mechanical or production engineering or sciences.
• Several years of professional experience in qualification, validation, or manufacturing engineering is a plus.
• Experience with equipment qualifications and process validations.
• Knowledge of Cp/Cpk, SPC, MSA, and DoE for statistical process analysis.

Aufgaben

• Plan, conduct, and document qualification of production facilities, equipment, and test equipment.
• Prepare and maintain IQ, OQ, PQ documentation and qualification strategies.
• Define acceptance criteria and assess changes on the qualified state.
• Plan requalifications and develop maintenance plans.
• Conduct DoE studies and DoE-based test planning and reporting.

Kenntnisse

Analytical thinking

Structured approach

Problem solving

Strong communication

Cross-site collaboration

Ausbildung

Bachelor’s or Master’s degree in mechanical/production/process engineering or sciences

Tools

BlueSky Statistics

MS Office

SAP

Jobbeschreibung

ENABLE your future through light. Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors. ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.

Responsibilities

• Planning, conducting, and documenting the qualification of production facilities, equipment, and test equipment
• Preparing and maintaining qualification documents (IQ, OQ, PQ)
• Defining qualification strategies and acceptance criteria
• Evaluating changes with regard to their impact on the qualified state
• Planning and conducting requalifications
• Developing maintenance plans
• Planning, conducting, and evaluating process validations
• Preparing validation plans, test reports, and final reports
• Identifying and evaluating critical process parameters and quality attributes
• Conducting statistical analyses and evaluating process and quality data
• Planning and conducting test series and Design of Experiments (DoE)
• Ensuring long-term process stability and process capability
• Conducting risk analyses (e.g., FMEA)
• Working closely with production, quality assurance, development, and maintenance

Required Qualifications

• Bachelor’s or master’s degree in mechanical engineering, production engineering, process engineering, natural sciences, or a comparable technical field
• Several years of professional experience in qualification, validation, or manufacturing engineering is a plus
• Experience conducting equipment qualifications and process validations
• Knowledge of statistical methods for process analysis and evaluation (e.g., Cp/Cpk, SPC, MSA, DoE)
• Proficiency with MS Office and, ideally, statistical and data analysis software (e.g., BlueSky Statistics)
• Experience with risk analyses and quality methods such as FMEA
• Structured approach to work, analytical thinking, and strong problem-solving skills
• Strong communication skills and the ability to collaborate across sites
• Good knowledge of Office 365 and SAP
• Fluent German (C1) and very good English (at least B2)

Equal Opportunity/Affirmative Action Employer

Minorities/Females/Disability/Gender Identity/Sexual Orientation

Excelitas is seeking leaders and innovators to join our global team! Visit: https://jobs.excelitas.com/