Process Scale-up Engineer
Location: Yuma, AZ
Department: Quality Dept
Reports To: Global Head of Quality
Assignment Type: full-time
The successful candidate will be responsible for the scale-up of formulated pesticide products from laboratory to manufacturing in order to support the successful launch of new formulations. The successful candidate will be responsible for ensuring compliance to Gowan Company’s pesticide registrations by conducting internal and external compliance reviews. The Process Scale-up Engineer will examine and analyze manufacturing and laboratory records, operating procedures, and other documentation to ensure that compliance with regulatory commitments are maintained; he/she will also be responsible for populating and maintaining an electronic records management system.
This position is expected to work across multiple functions to ensure consistency and continuous collaboration between multiple functions within the Gowan Company. The individual should be able to understand complex regulatory language, pesticide manufacturing processes, and analytical methodologies. The individual must be detail oriented, an effective communicator, and willing to travel up to 50% (domestically and internationally). The successful candidate should have a strong understanding of engineering principles, analytical methodologies and variance controls. This position will be located at Gowan Company in historic downtown Yuma AZ.
- Perform internal compliance reviews including those covering data integrity, out of specification investigations, and laboratory waste handling practices
- Perform compliance reviews of external toll manufacturing sites from planning to closure including; issuing inspection agendas; performing the inspections; drafting and issuing inspection reports; evaluation of any associated corrective actions that are identified; and verification and tracking of recommended corrective actions
- Appropriately escalate questionable practices and any identified non-compliant conditions to management
- Prepare and communicate summaries of operational compliance, identification of any non-compliance conditions, adequacy of investigations performed by the facility and any additional training required for facility personnel
- Recommend opportunities to strengthen control structures for toll manufacturing facilities
- Perform any needed follow-up activities including investigations and reviews
- Provide quality metric data for a Compliance Program Review
- Ensure successful technology transfers of formulated products to manufacturing sites
- Draft manufacturing specifications and manufacturing procedures
- Be responsible for planning and communicating scale-up and production trial activities
- Work collaboratively in a small but diverse team
- Minimum, BS in Chemistry/Analytical Chemistry/ Engineering Discipline
- Excellent laboratory skills, including detailed record keeping and knowledge of safe handling of chemicals and equipment
- Understanding of pesticide chemistries, pesticide regulations, formulation sciences, and manufacturing procedures
- Ability to use scientific principles/process/regulatory knowledge to identify compliance issues
- Effectively interact and communicate with various levels of personnel
- Effective verbal and written communication skills
- Ability to provide guidance and resolve conflicts
**Must be legally authorized to work in United States**
Send Resumes to:
Attn: Human Resources Dept.
370 S. Main St.
Yuma, AZ 85364