Sr. Manufacturing Engineer

We are seeking a Sr. Manufacturing Engineer with at least four (4) years of experience in manufacturing process design, validation, and production support within regulated environments. The ideal candidate has hands-on experience with process validation, equipment qualification (IQ), computer software validation, and troubleshooting manufacturing equipment, along with strong technical writing and communication skills.

Key Requirements:

• Bachelor’s Degree in Engineering
• Minimum of 4-6 years of experience in:
  • Manufacturing process design and optimization
  • Process Validation and Equipment IQ
  • Computer Software Validation
• Experience supporting manufacturing operations and production environments
• Hands-on experience in troubleshooting, investigation, and root cause analysis
• Knowledge of statistical techniques (SPC)
• Strong technical writing and documentation skills
• Effective communication skills (English and Spanish)
• Ability to manage schedules and meet project deadlines

Key Responsibilities:

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling
• Optimize plant layouts and workflow to ensure efficient and productive operations
• Develop sequences of operations and manufacturing procedures impacting product performance
• Adapt equipment and process designs to meet production and factory conditions
• Incorporate inspection and testing requirements into production plans
• Evaluate equipment and machinery performance, identify issues, and implement corrective actions
• Support process validation activities and ensure compliance with regulatory requirements
• Apply statistical techniques to improve and control manufacturing processes
• Provide technical support to manufacturing areas, including troubleshooting and sustaining engineering
• Collaborate with cross-functional teams and provide guidance on design and manufacturing best practices

Benefits:

• Paid time off (PTO)
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Employee discount
• Professional development assistance
• Referral program