Process Engineer

Responsibilities:

• Adhere to all safety protocols and comply with cGMP standards to ensure a safe and regulated work environment.
• Design, develop, and implement validation plans and protocols, focusing on optimizing manufacturing processes and ensuring rigorous validation of processes and equipment.
• Utilize Design of Experiments (DOE) methodologies to confirm the effectiveness and reliability of manufacturing processes.
• Conduct Installation Qualifications (IQ), Operational Qualifications (OQ), Process Challenges, and Performance Qualifications (PQ) for manufacturing equipment.
• Monitor and analyze critical quality attributes and process parameters to maintain product quality and minimize process variability.
• Collaborate on project teams to facilitate the launch of new products, equipment, and processes, ensuring seamless integration into manufacturing.
• Maintain meticulous documentation of process changes, improvements, and validations within the Quality Management System.
• Develop and refine manufacturing documentation, including routers, work instructions, Standard Operating Procedures (SOPs), and Bills of Materials (BOMs).
• Engage in technical teams for the investigation and resolution of deviations, validation of equipment and processes, and the introduction of new process technologies and significant procedural changes.
• Identify and propose process enhancements and corrective actions to increase efficiency, reduce costs, and improve product quality, ensuring compliance with regulatory standards.

Qualifications:

• Bachelor’s degree in Mechanical or Manufacturing Engineering, Science, Technical, or a related field.
• A minimum of 2 years' experience in a manufacturing setting, with a clear understanding of process validation and qualification.
• Demonstrated mechanical engineering capabilities, with proficiency in software such as Solidworks and AutoCAD.
• Excellent technical aptitude, with a proven track record of employing data-driven decision-making and maintaining strict process control.
• Effective communication skills, with the ability to articulate complex ideas clearly and collaborate effectively with cross-functional teams.
• Highly organized, self-motivated, and capable of solving complex technical issues through innovative thinking and a hands-on approach to problem-solving.
• Flexibility to work varying hours as business needs dictate, combined with a strong ability to maintain composure and effectiveness in challenging situations.

Preferred Qualifications:

• Previous experience specifically in validation engineering within a regulated environment.
• Background in silicone or plastic molding, extrusion, calendaring, assembly, or related manufacturing processes.
• Experience in the medical device sector and familiarity with cGMP manufacturing practices.
• Demonstrated ability to lead projects, with a keen focus on project management and leadership skills.

Job Type: Full-time

Pay: $90,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person
• Manufacturing facility

Ability to Relocate:

• Woodland, CA: Relocate before starting work (Required)

Work Location: In person