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Senior Validation Engineer
2 months ago
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 role requires a robust foundation in statistical methodologies, process oversight, and advanced data analytics.
Responsibilities include the application of established commercial biologics Continued Process Verification (CPV) strategies, contributing to the CPV initiatives for one or more biologics products.
Key tasks involve authoring, reviewing, and approving CPV protocols and reports, along with presenting CPV data to Subject Matter Experts (SMEs) as necessary.
The position also entails supporting data collection and verification activities related to batch processing.
The engineer will identify and implement enhancements for data collection and management, facilitating swift and reliable data analysis.
Additionally, the role provides statistical expertise for global commercial process monitoring, ensuring compliance with current ICH / Health Authority, QbD guidelines, and standard operating procedures (SOPs).
The engineer will assist in resolving investigations through statistical analysis.
This position involves working on moderately complex challenges where the analysis of situations or data necessitates a thorough evaluation of various factors.
The engineer will exercise judgment within generally defined practices and policies when selecting statistical methods, techniques, and evaluation criteria to achieve results.
Required Knowledge and Skills:
- Proficiency in optimization and statistical data analysis tools such as Minitab, JMP, Spotfire, and R. Basic programming skills in R and Python are preferred.
- Exceptional technical writing abilities.
- Familiarity with GMP and regulatory requirements pertinent to biopharmaceutical manufacturing is preferred.
- Strong troubleshooting skills and the capability to resolve complex technical challenges.
- Understanding of guidelines mandated by FDA, EMA, and other regulatory authorities.
- Extensive knowledge of industry practices.
- Excellent verbal, written, and interpersonal communication skills are essential.
- Ability to effectively manage multiple projects and priorities.
