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Validation Engineer - II

Clayton, NC 27527, USA

Job Type

Hybrid

Workspace

On-site

Responsibilities:
  • Strong background in statistics, process monitoring and advanced statistical data analysis.

  • Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.

  • Author, review and approve CPV protocols, reports and present CPV data as needed to Subject Matter Experts (SMEs).

  • Support batch processing data collection and verification activities.

  • Identifies and implements improvements for data collection and management to enable quick and reliable data analysis.

  • Provides statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.

  • Assist in resolution of investigations doing statistical analysis.

  • Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

  • Exercises judgment within generally defined practices and policies in selecting statistical methods, techniques and evaluation criteria for obtaining results.

Requirements

Knowledge and Skills
  • Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire and R. Basic programming in R and Python preferred

  • Excellent technical writing skill

  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred

  • Excellent troubleshooting skills and ability to solve complex technical issues.

  • Understanding of guidelines required by FDA, EMA, and other regulatory bodies

  • Extensive knowledge of industry practices.

  • Excellent verbal, written, and interpersonal communication skills are required.

  • Ability to effectively manage multiple projects/priorities.

About the Role

About the Company

Core, a Unicon Company, is a dynamic organization dedicated to providing innovative GxP compliance solutions to the life sciences industry. We are seeking talented and creative individuals to join our team and contribute to our continued success. We are committed to fostering a diverse and inclusive workplace where individuals from all backgrounds feel valued and respected. Our team is dedicated to delivering exceptional results and driving innovation in the field.

As an Equal Opportunity Employer, we do not discriminate employees and applicants on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Ready to join our team? Apply today through the link below.

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