Process Validation Engineer

Trumbull CT

Must have strong working knowledge in:

• 21CFR820, ISO13485:2016, ISO14971
• Process validation (IQ/OQ/PQ/TMV/MSA)
• Ideally both in transferring/scaling up existing processes as well as developing new processes
• NCMR, CAPA, Change control and GDP experience
• At least 3 years of experience in the medical device industry
• Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
• Presentation of results in a logical and clear manner
• Ability to analyze information and come to conclusions based on presented data
• Ability to communicate effectively both orally and in writing
• Strong organizational and interpersonal skills
• Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
• Background in statistics with respect to process control (reliability, capability, SPC, etc.)
• BS Degree in Life Science, Engineering or equivalent program is preferred

Qualifications

• Background in statistics with respect to process control (reliability, capability, SPC, etc.)
• BS degree in Life Science, Engineering or equivalent program is preferred

General Comments

• Someone with Strong Process Validation knowledge IQ OQ PQ TMV/MSA (Validation Master PLAN VMP-Manufacturing process experience)
• NCMR Capa experience crucial here
• MSA (GR&R) protocol and report writing, execution
• PFMEA execution
• Statistics general knowledge very Important here with respect to process control (sampling for validations, Sampling for in process inspections)
• Med Device experience
• Must have bachelors degree