Validation Engineer

Flexible & Integrated Technical Services, LLC•Juana Díaz, PR

1d•Onsite

About The Position

For Quality Engineering - Global Manufacturing Operations services in the Manufacturing area. This role involves evaluating systems, implementing validation packets, and identifying gaps. It provides validation to technology/manufacturing systems for in-line products and processes, and offers tactical direction for project teams implementing GMP systems. The role also includes developing and reviewing Standard Operating Procedures (SOPs) and supporting ongoing compliance initiatives, assessments, corrective actions, and training.

Requirements

Bachelor’s Degree in Engineering or Life Sciences
Three (3) to five (5) years of exposure to Quality Validations within the regulated industry.
Developing, Executing, and Reviewing Validations Life Cycles Protocols.
Testing and Development of Statistical Process Control.
Validation design, testing and development of statistical process control and monitoring.
Product design, costing and production requirements.
Bilingual English/Spanish, both written and verbal

Nice To Haves

Lean Six Sigma certification preferred.
Medical Device industry is a definite plus.

Responsibilities

Able to evaluate systems, implement validation packets, and identify existing or potential gaps
Provides validation to technology/manufacturing systems in support of manufacturing sites for in-line products and processes
Provides tactical direction and guidance for project teams implementing various activities for new and existing GMP systems.
Develops and reviews Standard Operating Procedures (SOPs).
Provides support for ongoing compliance initiatives, assessments, corrective actions, and training.
Based on equipment capabilities, generate and execute quality validation protocols (IQ, TMV, TQF, Process Characterization, and Process Validation).
Conduct validation of process equipment installation/operational/performance qualification studies to test their functionality.
Prepare operational qualification assessments to support the fact that validated critical operating parameters are within qualified parameters.
Identify and evaluate equipment enhancements to support intended qualified operational ranges.
Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
Support process capability and statistical analysis related to equipment performance.