Validation Engineer

NETZSCH Grinding & Dispersing

Have we created your interest? Please send us your application papers. We look forward to receive your application!

NETZSCH Premier Technologies, LLC.
Barbara White
125 Pickering Way
Exton, PA 19341
Phone: 484-879-2020
Fax: 610-280-1299
e-mail: npt‎hr@‎netzsch.com

NETZSCH Premier Technologies, LLC. ia a member of the NETZSCH Business Unit Grinding & Dispersing - one of the world’s market leaders in wet processing technology offering an extensive range of products from laboratory to production sized machines and complete plants. Mixers, kneaders or dispersers for low or high-viscosity products are available for a multitude of applications just as well as a large number of wet grinding systems for different grinding tasks even down to the nanometer range.

NETZSCH Premier Technologies, LLC, has an opening for a

Validation Engineer

This position will prepare validation protocols and technical specifications for new systems and equipment used in the Pharmaceutical/Biotech Industry such as User Requirement Specification; Risk Assessment, Functional Specification, Traceability Matrix(TM), Design Specifications, Qualification Protocols, etc.  This position conducts validation or qualification tests of new or existing equipment, processes and software in accordance with internal or customer protocols.

Essential Duties and Responsibilities:

  • Prepares, executes, maintains and reviews engineering, validation and compliance documentation such as FS, SDS, DQ, TM, FAT, SAT, IQ, OQ, and/or IOQ, engineering change notice protocols and reports. 
  • Executes and document FAT, COMM, SAT, IQ, OQ, and/or IOQ, test protocols at customer facilities. 
  • Independently coordinates and executes document (above) reviews with customer project, quality and or validation departments. 
  • Independently coordinates the scheduling of validation activities with project manager, end customer and Netzsch affiliates.
  • Analyze validation test data to determine if systems have met validation criteria.
  • Resolves testing problems and revises test cases as necessary.
  • Assists in training equipment operators or other staff on validation protocols and standard operating procedure at equipment manufacturer and customer facility. 
  • Is actively involved with the quality testing and validation of process equipment.
  • Provides quality engineering support in supplier quality assessments and customer audits.
  • Work with Mechanical, Electrical and Automation engineering team members to identify, resolve and document issues found during equipment testing.
  • Provides advice and feedback on corrective actions. 
  • Performs final testing (FAT) directly with customer representatives on industrial and pharmaceutical equipment.
  • Other duties as required.

Position Requirements:

  • Bachelor Degree or Associated Degree in Biopharmaceutical, Electrical, Mechanical or Chemical Engineering and a minimum of 3 years of experience with an emphasis on pharmaceutical equipment validation.
  • Familiar with Good Manufacturing Practice (GMP), GAMP 5 Standards, Quality System Regulations, FDA regulatory requirements, ISO Quality Standards and 21 CFR Part 11 Computer System Validation standards.
  • Current driver’s license and passport (or the ability to obtain one upon hire).
  • SAP and internet technologies
  • Experienced in setup and operation of Kaye Validation software desirable

If you are interested and qualify for this position, please contact Mike Parker (x282) or Nicole Thompson (x108) or send your resume to npthr@netzsch.com.

We are an EEO Employer.

Apply now