Job Title: Cleaning Validation Engineer
Location: Princeton, New Jersey
Duration: 12-Month Contract (Potential for Sponsorship)
About the Role:
We are seeking a highly skilled and experienced Cleaning Validation Engineer to join our dynamic team in Princeton, NJ. This is a critical role responsible for ensuring the cleanliness and compliance of our biotech and pharmaceutical manufacturing processes. You will be instrumental in generating, executing, and reporting on testing for all phases of commissioning and qualification. This position offers an exceptional opportunity to contribute to the quality and safety of life-changing therapies within a cGMP environment.
Responsibilities:
Comprehensive Validation: Generate, execute, and report on testing for multiple phases of commissioning and qualification, focusing on cleaning and process engineering.
Post-Cleaning Monitoring: Conduct post-cleaning validation monitoring and analyze data to ensure adherence to established acceptance criteria.
Cycle Development & Optimization: Develop, troubleshoot, and optimize cleaning cycles and systems, including CIP (Clean-In-Place), COP (Clean-Out-of-Place), and manual cleaning procedures.
System Expertise: Demonstrate hands-on experience with CIP, SIP (Sterilization-In-Place), cabinet washers, COP, and manual cleaning systems.
Documentation & Reporting: Develop detailed validation reports, SOPs, and other GxP documentation.
Data Analysis & Interpretation: Analyze data, interpret results, and present conclusions and recommendations to ensure projects are implemented within agreed scope, timelines, policies, and procedures.
Discrepancy Resolution: Generate and resolve protocol discrepancies or deviations.
GxP Compliance: Review GxP deliverables, including specifications, drawings, procedural documents, master plans, and validation documentation.
Training & Collaboration: Train operations staff on protocols, procedures, and technical details related to systems or processes. Collaborate with cross-functional teams.
Project Management: Organize, schedule, and track validation projects to meet client requirements and agreed timelines.
Sampling Techniques: Demonstrate experience with various sampling techniques.
Tablet Press Protocol Development: Experience with the development of manual cleaning protocols for tablet press equipment is highly preferred.
Discrepancy & CAPA: Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems, and root cause analysis.
Qualifications:
Bachelor's degree in a scientific or engineering discipline (e.g., Chemical Engineering, Microbiology, or related field).
Proven experience in cleaning validation within the biotech or pharmaceutical industry.
Strong working knowledge of cGMP requirements and industry best practices.
Hands-on experience with CIP/COP systems, SIP systems, cabinet washers, and manual cleaning procedures.
Proficiency in data analysis and interpretation.
Excellent written and verbal communication skills.
Strong problem-solving, decision-making, and experimental design skills.
Ability to understand and extract necessary information from technical documents.
Ability to handle complex projects and prioritize activities.
Takes initiative to help drive projects forward and develop contingency plans.
Ability to work on cross-functional project teams.
Proven ability to review, interpret, and make scientific conclusions and recommendations based on data.
Ability to work independently, handle multiple tasks simultaneously, and meet critical milestones and goals.
Effectively work within a team environment and interface with peers, management, etc.
Strong organizational skills and demonstrated ability to manage projects to completion.
Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint, and Visio.
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