The Validation Engineer will be responsible for planning and controlling day-to-day activities within the project plan and providing support of production manufacturing process and procedures. The Validation Engineer will coordinate with the Quality Department on the initiation of projects through proper Change Control Management procedures and by defining and developing manufacturing processes for any company products as needed. This role is responsible for reviewing design documentation for completion and accuracy, remaining up to date with current Good Manufacturing Practices (GMP), and maintaining a good understanding of the part that engineering design plays in the successful validation of a manufacturing facility.
The Validation Engineer will create and maintain process documenta??on including process flow charts, characteristic matrix, processillustrations, PFMEA, control plans, process sheets, visual aids, gage instructions, control charts and others. He or she will implement a well-defined Good Engineering Practice (GEP), establish engineering methods and standards that are applied throughout the project lifecycle to deliver appropriate and cost-effective solutions, at the initiation of the project to simplify validation procedures by addressing engineering related issues that are important to the validation effort as they emerge. The Validation Engineer will perform GMP reviews, facility layout, material and personnel flow, equipment specifications and system boundaries.
The Validation Engineer will utilize good problem solving, corrective action and root cause analysis principles, drive technical requirements, support sourcing decisions and manage equipment integrator and tool vendor activities for plant production equipment, gauges and tooling. He or she will focus on recent changes to the GMP regulations that affect engineering design and validation, ISPE concepts, Maintenance qualification, Cost Reduction, simplicity and will discuss the extent to which changes can affect the manufacturing process during the design phase of the project.
The Validation Engineer will manage the Life-cycle documenta??on covering planning, specification, design, verification, installation, acceptance, andmaintenance as produced as part of GEP. He or she will perform Project Infrastructure, Project Organization and Value Analysis.
Bachelor's Degree in Mechanical, Manufacturing or Industrial Engineering
Superior interpersonal skills
Highly developed organizational and management skills
Excellent verbal and written communication skills
Ability to travel as needed
Strong conceptual, as well as quantitative and qualitative analytical skills
Manufacturing engineering skills
Process improvement skills
Manufacturing process skills
Tooling, tooling fixtures, automation skills
Effective communication skills
Outstanding analytical and problem-solving skills
Experience in the applicable utilization of standard/specialized industrial cleaning equipment
Ability to assume ownership of significant portions of tasks while collaborating with a close-knit team
Ability to schedule equipment/ personnel efficiently/ effectively for daily maintenance/project work
Successfully resolve customer/employee complaints
***If interested, please email resume for immediate consideration!***
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chanc
