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:

• Bachelors 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 datadriven decisionmaking and maintaining strict process control.
• Effective communication skills with the ability to articulate complex ideas clearly and collaborate effectively with crossfunctional teams.
• Highly organized selfmotivated and capable of solving complex technical issues through innovative thinking and a handson approach to problemsolving.
• 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.

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

Remote Work :

No