Cleaning Validation Associate
: Job Details :

Overview:

This Cleaning Validation Associate will support the Cleaning Validation program, including equipment processes and procedures for commercial and new R&D drug development activities at the Lakewood, NJ plant. The role involves assisting in the generation, review, and approval of protocols, deviations, and reports; scheduling manpower activities; and providing feedback to both internal and external customers. The associate will help manage Cleaning Validation activities, including Development, Verifications, Validations, and Monitoring, under the guidance of a senior specialist. Regular interaction with regulatory and compliance personnel is expected to ensure adherence to FDA and international regulations. The associate will also assist in representing Renaissance to customers and senior management, contributing to the overall compliance and quality of our validation efforts.

Responsibilities:

1) Technical Support: Assist in understanding and applying the principles of Cleaning Validation for development, verification, validation, and monitoring. 2) Data Analysis: Support the development of Design of Experiments (DOEs) and statistical sampling plans. Perform basic statistical analysis and assist in evaluating data to support technical decisions. 3) Batch Records: Help review Master Batch Records to ensure they align with the validated state of cleaning processes and support manufacturing schedules. 4) Validation Activities: Perform cleaning validation tasks (such as sampling) within a pharmaceutical environment, ensuring adherence to aseptic and sanitary conditions. 5) Regulatory Compliance: Implement and follow applicable regulatory requirements, including FDA, ISO, and EMA guidelines, to ensure compliance. 6) Resource Management: Assist in scheduling and planning resources to support cleaning validation efforts and meet project timelines. 7) Team Communication: Communicate expectations and updates to the Cleaning Validation team. Assist in reporting team progress and priorities to Validation management. 8) Customer Interaction: Support interactions with customers regarding transfer discussions, timelines, and project deliverables. 9) Time Management: Manage personal tasks effectively and assist in maintaining team timelines. Report on project status and team performance to cross-functional teams and site leadership. 10) Program Planning: Contribute to the generation and maintenance of site program plans and the validation master plan. 11) Root Cause Analysis: Collaborate with area owners to identify potential root causes and recommend preventive and corrective actions. 12) Regulatory Discussions: Assist in discussions with regulatory agencies, quality assurance, or clients as needed. 13) Process Review: Support the review of SOPs and internal processes to ensure they comply with quality standards and cGMP regulations. 14) Compliance and Improvement: Identify potential compliance issues and areas for improvement.

Qualifications:

Bachelor of Science degree in a Science, Engineering or other related field required. Advanced education is preferred.

Additional education in project or documented investigational course work and experience with cGMP software such as Trackwise preferred but not necessary.

Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.