QA Validation Engineer I

Background

¨ Works under general supervision of the Quality Assurance Manager in a c-GMP regulated manufacturing environment operating under Q7A standards.

¨ Employees in positions at this level rely on limited experience and judgment to plan and accomplish validation quality activities for a vast spectrum of c-GMP equipment, facilities, systems and processes. A narrow degree of creativity and latitude is expected.

Tasks

¨ Review daily production batch records for compliance; approve and release for shipment or sale; assist in resolution of deviations if detected

¨ Develop and prepare protocols, assist in implementation and report results for assigned validation work

¨ Work closely with Research & Development laboratory, Production and Process Engineering departments to assure coordination and consistency of purpose

¨ Analyze and improve existing products, equipment, processes or designs as assigned

¨ Support development of products by building prototypes and testing them to optimize product development time

¨ Investigate, establish and implement requirements for equipment, tooling, materials and methods for production and validation

¨ Create documentation to support existing products, processes and equipment in accordance with regulatory requirements

¨ Provide hands-on troubleshooting as necessary

¨ Support production and development of new products and processes through independent review, root cause analysis, corrective action, discrepancy handling and defect prevention

¨ Participate in cost reduction and cost of quality programs

¨ Maintain current knowledge of industry practices and regulations related to company products

¨ Maintain and enhance site safety

Specifications

¨ B.S. in Chemistry, Chemical Engineering or related technical field

¨ Two (2) years of validation engineering experience in a manufacturing environment

¨ Knowledge of:

o c-GMP validation practices (Basic level)

o FDA and other US regulations (Basic level)

o MS Office software package (Basic level)

¨ Skill in:

o Developing creative solutions to non-routine validation problems

o Data processing with attention to detail and documentation

o Working effectively and efficiently on multiple projects at once

o Working effectively independently and in a team environment

o Responding to rapidly changing demands

¨ Ability to:

o Execute c-GMP validation activities

o Manage cross-functional projects and present a strong floor presence

o Generate schematics and drawings

o Communicate effectively, orally and in writing with technical material

o Review, compile and verify technical data and documents

o Identify, gather, process and record data accurately

FLSA

¨ Exempt

To apply or get additional information, contact:

Jost Chemical Co.
ATTN: Human Resources
8150 Lackland Rd
St Louis MO 63114

FAX: 314.813.1906

Email: jobs@jostchemical.com

Their online application is at employment application