Quality Engineer (GMP/Pharma Manufacturing)

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Role: GMP Quality Assurance Engineer / Quality Systems Engineer

Location: Phillipsburg, NJ (Onsite M-F)

Duration: 18 Months Contract-to-Hire

Client: Avantor

Interview Process: 15-min Teams 2-hour onsite interview

Job Description:

The ideal candidate will have experience in pharmaceutical, biotech, or chemical manufacturing environments and strong knowledge of cGMP and ISO standards.

Required Skills:

• 5 years of Quality Engineering / Quality Assurance experience
• Experience in pharmaceutical, biotechnology, chemical, or GMP manufacturing environments
• Strong knowledge of cGMP, ISO 9000, FDA regulations, CAPA, audits, validation
• Experience handling customer complaints and investigations
• Background in Quality Systems and compliance programs
• Bachelor’s degree in chemistry or related Science field
• Excellent communication and analytical skills
  
  

Preferred Skills:

• Experience with ICHQ7, IPEC guidelines
• Stability, SPC, validation experience
• Internal/supplier audit experience
• GMP/GDP training experience
  
  

Responsibilities:

• Lead quality assurance and compliance programs
• Manage CAPA and complaint investigations
• Support GMP, ISO, regulatory, customer, and internal audits
• Perform validation and statistical evaluations
• Drive quality improvements and corrective actions
• Collaborate with operations, suppliers, and customers
• Ensure ongoing compliance with FDA and ISO standards
  
  

Work Environment:

• Manufacturing facility environment
• PPE required in designated areas
• Occasional domestic travel