Contamination Control Risk Management Specialist

2 weeks ago


Conshohocken, Pennsylvania, United States PharmaLex Full time
Job Overview

PharmaLex is a prominent consulting firm dedicated to the Healthcare sector, currently experiencing a surge in demand for Contamination Control Experts. We aim to expand our network of consultants to meet the needs of upcoming projects. Our organization fosters a work environment that prioritizes trust, respect, collaboration, creativity, enthusiasm, and diligence.

We are in search of seasoned professionals with expertise in Contamination Control Risk Assessment & Strategy Initiatives:

Work Arrangement: Options available for either ONSITE or REMOTE work.
Project Duration: Estimated at 100+ hours over a period of 3-4 weeks.

A successful candidate in the US should possess the following Technical Qualifications:

  • A Bachelor's degree (or higher) in Microbiology, accompanied by over 10 years of relevant experience in commercial aseptic processing within pharmaceutical Quality Operations or QA Validations.
  • Proficient understanding of ICH Q9 and EU Annex 1 as they pertain to microbial risk assessments.
  • Formal training and practical experience with FMEA and quantitative risk analysis methodologies are essential.
  • Hands-on experience with validation requirements that support sterility assurance for Bio/Pharma/ATMP products.
  • Strong familiarity with EU and US cGMPs and their relevance to manufacturing operations in a biologics context is preferred.
  • Experience in cell and gene therapy and/or Rapid Micro Methods (RMM) is advantageous.
  • Direct involvement in leading root cause analysis or sterility assurance investigations is a plus.

To join the PharmaLex network for this and similar projects, candidates must demonstrate the following Core Competencies:

  • Proficient writing and speaking skills in English and/or Spanish.
  • A minimum of 3 years of experience in people management and team facilitation.
  • Advanced regulatory knowledge gained through experience in the pharmaceutical industry.
  • Direct experience within a pharmaceutical manufacturing environment.
  • Ability to collaborate across functional areas, or previous client engagement experience, such as with CMO or similar.
  • Proven ability to facilitate and mentor a team; PMP certification is a plus.
  • Strong analytical reasoning abilities and lateral thinking across various functions.

PharmaLex is an Equal Opportunity Employer.

We are committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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