Validation Engineer

Responsibilities:

• Apply cGMP standards..
• Understand manufacturing and packaging processes.
• Perform swab and TOC testing.
• Conduct microbiological testing.
• Use lab data and real-world knowledge to investigate and identify failure points.
• Apply matrix and risk-based validation methodologies.
• Establish microbiological controls in manufacturing and packaging environments.
• Perform studies using coupons to validate cleaning effectiveness and procedures.
• Develop methods to reduce or eliminate cross-contamination and microbiological issues.
• Write validation protocols and summary reports.
• Utilize statistical analysis software to identify trends and analyze CPK/PPK values.
• Collaborate with Research and Development to determine test markers and levels based on product composition.
• Preferred experience with TOC, HPLC, and GC for testing samples.

Qualifications:

• Degree in Biology, Microbiology, or Chemistry (Microbiology preferred).
• Minimum of 3 years of experience in a related field.