Cleaning Validation Associate

2 weeks ago

Lakewood, United States GQR Full time

Job Title: Cleaning Validation Associate

Status: Full-time direct hire, benefits available day 1.

Location: Lakewood, NJ

Compensation: $75,000 annual salary

Overview:

This position 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.

Responsibilities:

  • Technical Support: Assist in understanding and applying the principles of Cleaning Validation for development, verification, validation, and monitoring.
  • 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.

Batch Records: Help review Master Batch Records to ensure they align with the validated state of cleaning processes and support manufacturing schedules.

  • Validation Activities: Perform cleaning validation tasks (such as sampling) within a pharmaceutical environment, ensuring adherence to aseptic and sanitary conditions.
  • Regulatory Compliance: Implement and follow applicable regulatory requirements, including FDA, ISO, and EMA guidelines, to ensure compliance.
  • Resource Management: Assist in scheduling and planning resources to support cleaning validation efforts and meet project timelines.
  • Team Communication: Communicate expectations and updates to the Cleaning Validation team. Assist in reporting team progress and priorities to Validation management.
  • Customer Interaction: Support interactions with customers regarding transfer discussions, timelines, and project deliverables.
  • 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.
  • Program Planning: Contribute to the generation and maintenance of site program plans and the validation master plan.
  • Root Cause Analysis: Collaborate with area owners to identify potential root causes and recommend preventive and corrective actions.
  • Regulatory Discussions: Assist in discussions with regulatory agencies, quality assurance, or clients as needed.
  • Process Review: Support the review of SOPs and internal processes to ensure they comply with quality standards and cGMP regulations.
  • 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.

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