PharmaLex is hiring a
Contamination Control Risk Assessment & Strategy Consultant

Summary

The job is for a Contamination Control Consultant at PharmaLex, a growing consulting company in the Healthcare industry. The role involves performing Contamination Control Risk Assessment & Strategy Projects and can be done onsite or remotely. The ideal candidate should have a Bachelor’s degree in Microbiology and 10+ years of relevant experience.

Requirements

• Bachelor’s degree (or higher) in Microbiology and 10+ years of relevant experience in commercial aseptic processing pharmaceutical Quality Operations or QA Validations
• Working knowledge of ICH Q9 and EU Annex 1 as applies to microbial risk assessments
• Formal training and hands-on experience with FMEA and quantitative risk analysis methods is required
• Direct experience with validation requirements supporting sterility assurance of Bio/Pharma/ATMP products
• Demonstrated writing & speaking fluency in English and/or Spanish
• 3+ years previous people management experience facilitating a team
• Advanced regulatory knowledge acquired through experience in the pharma industry
• Direct experience in a pharmaceutical manufacturing site

Responsibilities

Perform Contamination Control Risk Assessment & Strategy Projects

Preferred Qualifications

• Strong knowledge of EU and US cGMPs and applicability to manufacturing operations in a biologics environment is preferred
• Experience in cell and gene therapy and/or Rapid Micro Methods (RMM) is a plus
• Direct experience leading root cause analysis or sterility assurance investigations is a plus
• Ability to work across functional areas, or previous client engagement experience, such as CMO or similar
• Demonstrated ability to facilitate and coach a team, PMP certification a plus
• Strong analytical reasoning skills and lateral thinking across functions

Benefits

• Work Arrangements: Either ONSITE or REMOTE
• Duration: Approximately 100+ hours in a span of 3-4 weeks