Overview
On Site
Full Time
Skills
Product Development
Technical Drafting
Data Analysis
Performance Testing
Value Stream Mapping
Collaboration
Document Management
Statistics
Process Mapping
Capacity Management
Documentation
QMS
Test Methods
System Requirements
ISO 13485
GMP
Manufacturing
Schematics
Writing
IQ
OQ
PQ
Quality Management
Communication
Fluency
English
Job Details
Job Description:
- The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation.
- The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics.
- This position will also support other projected related tasks such as developing strategies and protocols for performance testing, time study and value stream mapping, and development of equipment functional and user requirements.
- Collaborate with Engineering and Quality on equipment / process changes, additions and installs for how to qualify equipment, processes and newly developed coatings.
- Preparing and reviewing validation protocols, engineering study reports, results from trials and test work, parameter development and operational qualifications, including challenge tests to establish and demonstrate stable processes and capability. Collaborate with document control to approve and release into QMS.
- Perform basic to intermediate statistics for the analysis of data.
- Update, where necessary, the Validation Master Plan with outcomes of executed qualifications / validations.
- Lead and support process time studies, value stream and process mapping, and capacity analysis.
- Support development of user, functional, and equipment requirement for new and existing equipment.
- Work within the established company-wide quality documentation system and QMS, including key aspects such as executing and supporting test methods per procedure, collecting and documenting test results, writing test data reports and procedures.
- Follow Quality Management System requirements in an ISO 13485 / GMP manufacturing environment.
- Minimum of 7 yrs experience in engineering or equivalent and an engineering bachelor's degree.
- Can interpret schematics, engineering drawings, written and verbal instructions.
- Understands the operation and functionality of process equipment; conducts tests and reports data in prescribed format.
- Experience in planning, preparing and executing validations protocols and reports, writing and implementing procedures, development of processing parameters, executing and documenting trials, IQ/OQ/PQ, navigating quality management systems.
- Strong computer and communication skills. Fluent in English, both written and spoken.
- Minimum of 7 yrs experience in engineering or equivalent and an engineering bachelor's degree.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.