The Process Engineer/Validation Engineer will be responsible for supporting Continued Process Verification (CPV) activities for biologics products. The role requires a strong background in statistics, process monitoring, and advanced statistical data analysis. This individual will collaborate with Subject Matter Experts (SMEs) to author, review, and approve CPV protocols and reports, support batch processing data collection, and ensure compliance with regulatory guidelines. The ideal candidate will bring statistical expertise, a solid understanding of biopharmaceutical manufacturing processes, and the ability to handle complex technical challenges.
Key Responsibilities:
- Apply established commercial biologics Continued Process Verification (CPV) strategies and contribute to CPV programs for one or more biologics products.
- Author, review, and approve CPV protocols and reports, presenting CPV data to Subject Matter Experts (SMEs) as required.
- Support batch processing data collection, verification activities, and ongoing process monitoring.
- Identify and implement improvements for data collection and management to enable efficient and reliable data analysis.
- Provide statistical expertise for global commercial process monitoring in line with ICH guidelines, QbD principles, and regulatory requirements.
- Conduct statistical analysis to assist in the resolution of process-related investigations.
- Work on moderately complex problems requiring an in-depth analysis of data and situations, applying statistical methods, techniques, and evaluation criteria.
- Ensure compliance with GMP and biopharmaceutical regulatory guidelines, including FDA, EMA, and other health authority requirements.
Required Qualifications:
- Bachelor’s degree in a relevant scientific discipline with 4+ years of experience or a Master’s degree with 2+ years of experience in a relevant field.
- Strong background in statistics, process monitoring, and advanced statistical data analysis.
- Experience with statistical data analysis tools such as Minitab, JMP, Spotfire, and R; basic programming skills in R and Python are preferred.
- Excellent technical writing skills with experience authoring reports and protocols.
- Strong understanding of GMP and biopharmaceutical manufacturing regulations and requirements.
- Ability to solve complex technical issues and manage multiple projects and priorities effectively.
Preferred Qualifications:
- Familiarity with regulatory guidelines from the FDA, EMA, and other governing bodies.
- Extensive knowledge of industry best practices related to process verification and statistical analysis.
- Strong troubleshooting skills and ability to communicate technical concepts clearly across different teams.
Skills & Competencies:
- Proficiency in statistical analysis and data visualization tools (Minitab, JMP, Spotfire, R).
- Strong verbal and written communication skills, with the ability to present complex data to various stakeholders.
- Excellent organizational skills and ability to manage multiple projects in a fast-paced environment.