GMP-CQ Engineer | DoE, CAPA & Data Analysis

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 85,000 - 95,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a qualified individual for equipment commissioning and qualification tasks in Tamarac, FL. The successful candidate will perform investigations into equipment failures, write qualification protocols, and ensure compliance with safety regulations.

We are looking for candidates with a Bachelor's degree in engineering, strong analytical skills, and two years of relevant experience in the pharmaceutical or medical device industry. Join us in maintaining the high quality of our operations!

Qualifications

• Two years of experience in commissioning and qualification in pharmaceutical or medical device industry.
• Experience with ASQ Quality Engineer Certification (CQE) is a plus.

Responsibilities

• Perform investigations into equipment failures and materials issues.
• Write and execute commissioning and qualification protocols.
• Support implementation of Corrective and Preventive Actions (CAPA's).
• Perform Periodic Qualification Certifications.
• Work with Quality Assurance and suppliers on materials specifications.
• Identify root causes and develop solutions to problems.
• Ensure compliance with company policies including safety regulations.

Skills

GMP

CFR

ICH

Statistics and Data Analysis

Project Management

Production equipment, instrumentation, and automation

Commissioning and Qualification

Engineering investigations

Microsoft Word

Microsoft Excel

Microsoft Project

Minitab

Education

Bachelor’s Degree in engineering discipline

Master’s Degree

Job description

Aveva Drug Delivery Systems is seeking a qualified individual for equipment commissioning and qualification tasks in Tamarac, FL. The successful candidate will perform investigations into equipment failures, write qualification protocols, and ensure compliance with safety regulations.

We are looking for candidates with a Bachelor's degree in engineering, strong analytical skills, and two years of relevant experience in the pharmaceutical or medical device industry. Join us in maintaining the high quality of our operations!