Manufacturing Specialist

Responsibilities

• Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
• Serve as subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
• Set up, operate, troubleshoot, and perform advanced adjustments on manufacturing equipment.
• Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
• Identify, investigate, and resolve manufacturing issues while ensuring compliance with approved procedures and quality requirements.
• Lead/support deviation and nonconformance investigations, root cause analyses, CAPAs, and other quality system activities.
• Support process validation, equipment qualification, engineering studies, and technology transfer.
• Develop/revise/improve manufacturing procedures, work instructions, forms, and training materials.
• Train/mentor/qualify manufacturing personnel; support onboarding and development.
• Partner with Quality, Engineering, Supply Chain, and Regulatory to support manufacturing objectives.
• Drive continuous improvement and monitor manufacturing metrics.
• Assist with capacity planning, production readiness, and scheduling.
• Maintain areas in inspection readiness; promote safety, quality, accountability, and continuous improvement.

• Advanced cGMP, GDP, and quality system requirements; strong combination product manufacturing knowledge.
• Expertise in manufacturing documentation and batch record execution.
• Advanced troubleshooting; ability to lead investigations and identify root causes.
• Technical aptitude with manufacturing equipment/automated systems; electronic quality management systems preferred.
• Organizational/communication skills; train/mentor ability; lead projects/process improvements.
• Work independently; sound judgment.
• Lift up to 25 lbs; wear PPE/cleanroom gowning.
• Stand/walk/bend/reach/repetitive motions; requires an eye exam.

• 5+ years in a regulated manufacturing environment.
• Medical device, pharmaceutical, biotech, or combination product manufacturing experience.
• Experience supporting investigations, process improvements, equipment troubleshooting, and training.
• Lead operator/trainer/SME experience preferred.

• High School Diploma or GED required;
  Associate’s/Bachelor’s in a technical field preferred.

$36.06 USD - $47.04 USD