Senior Validation Specialist

2 weeks ago


Parsippany, New Jersey, United States Careerbuilder-US Full time

Job Title: Validation Engineer - II

Job Location: Parsippany, NJ (Hybrid role)

Job Duration: 6 Months (Possible extension)

Hybrid - Onsite T/W/Th
Working hours: 8-4:30, 8:30-5, 9-5:30 type of hours (most of team works 9-5)

Job Overview:

The Validation Engineer will leverage a robust background in statistical methodologies and process oversight to enhance the Continued Process Verification (CPV) initiatives for biologics products.

Key Responsibilities:

1. Utilize advanced statistical analysis to support and improve the CPV program for various biologics products.

2. Develop, review, and endorse CPV protocols and reports, presenting findings to Subject Matter Experts (SMEs) as necessary.

3. Facilitate data collection and verification activities related to batch processing.

4. Identify and implement enhancements in data management practices to promote efficient and reliable data analysis.

5. Provide statistical guidance for global commercial process monitoring, ensuring compliance with ICH, Health Authority, and Quality by Design (QbD) standards.

6. Assist in the resolution of investigations through comprehensive statistical analysis.

7. Tackle moderately complex challenges requiring detailed evaluation of various factors.

8. Apply sound judgment in selecting appropriate statistical methods and evaluation criteria to achieve desired outcomes.

Required Skills and Qualifications:

- Proficiency in optimization and statistical analysis tools such as Minitab, JMP, Spotfire, and R; familiarity with programming in R and Python is advantageous.

- Strong technical writing capabilities.

- Understanding of Good Manufacturing Practices (GMP) and regulatory standards within biopharmaceutical production is preferred.

- Exceptional troubleshooting skills and the ability to address complex technical challenges.

- Knowledge of FDA, EMA, and other regulatory body guidelines.

- Comprehensive understanding of industry practices.

- Excellent verbal, written, and interpersonal communication skills.

- Ability to effectively manage multiple projects and priorities.



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