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
