Manufacturing Specialist

Scorpion Therapeutics; Worcester (MA); On-site; USD 75,000 - 98,000; Full time

Job summary

Scorpion Therapeutics in Worcester, MA is seeking an experienced Manufacturing Technician to perform and supervise complex production steps in a regulated environment.

You will act as SME for multiple processes/equipment, drive deviations investigations, support validation, and contribute to continuous improvement, safety and training of personnel.

Qualifications

• Advanced cGMP, GDP, and quality system requirements.
• Expertise in manufacturing documentation and batch record execution.
• Advanced troubleshooting; lead investigations and identify root causes.
• Technical aptitude with manufacturing equipment/ automated systems.

Responsibilities

• Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
• Serve as 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 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.

Skills

cGMP knowledge

Quality systems

Documentation mastery

Root cause analysis

Troubleshooting

Equipment operation

Education

High School Diploma or GED

Technical degree preferred

Job description

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.

Required Skills/Knowledge

• 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.

Experience

• 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.

Education

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

Salary Range

$36.06 USD - $47.04 USD