Validation Engineer (f/m/d)

Excelitas Technologies Corp.; Göttingen; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Excelitas Technologies Corp. is seeking a qualified engineer to plan, conduct, and document qualification of production facilities, equipment, and test equipment in a manufacturing environment.

The role involves preparing IQ/OQ/PQ documents, defining qualification strategies, performing process validations and DoE studies, and conducting risk analyses such as FMEA, with close collaboration across production, quality assurance, development, and maintenance.

Qualifikationen

• Degree in a technical field (mechanical/production/process engineering or natural sciences).
• Several years of experience in qualification, validation, or manufacturing engineering is a plus.
• Experience with equipment qualifications and process validations.
• Knowledge of Cp/Cpk, SPC, MSA, DoE and statistical methods.
• Proficiency with MS Office and statistical software (BlueSky Statistics).
• Experience with risk analyses and quality methods such as FMEA.
• Structured, analytical work style with strong problem-solving and collaboration across sites.
• Fluent German (C1) and very good English (B2 or higher).

Aufgaben

• Plan, conduct, and document qualification of production facilities, equipment, and test equipment.
• Prepare and maintain qualification documents (IQ, OQ, PQ).
• Define qualification strategies and acceptance criteria.
• Evaluate changes for impact on the qualified state.
• Plan and conduct requalifications.
• Plan, conduct, and evaluate process validations.
• Prepare validation plans, test reports, and final reports.
• Identify and evaluate critical process parameters and quality attributes.
• Conduct statistical analyses and evaluate process and quality data.
• Plan and conduct DoE studies.
• Ensure long-term process stability and process capability.
• Conduct risk analyses (e.g., FMEA).
• Work closely with production, quality assurance, development, and maintenance.

Kenntnisse

Analytical thinking

Communication skills

Problem solving

Cross-site collaboration

Ausbildung

Bachelor’s or Master’s degree in mechanical engineering, production engineering, process engineering, natural sciences, or a comparable technical field

Tools

BlueSky Statistics

MS Office 365

SAP

Jobbeschreibung

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Location:
Goettingen, DE, D37081

Job Function: Operations - Engineering

Job Country: Germany

Job Type: Regular Full Time

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
• 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