What are the responsibilities and job description for the Validation Engineer Senior position at Aditi Consulting?
Payrate: $55.00 - $60.00/hr.
Summary:
We are seeking a highly experienced professional to lead and execute Cleaning Validation activities. The ideal candidate will have extensive field execution experience, a deep understanding of cleaning validation lifecycles, and proficiency with KNEAT. This role requires flexibility to work non-traditional hours, including nights and weekends, based on project and business needs.
Responsibilities:
- Lead the execution of all Cleaning Validation activities, including protocol generation, field execution, data retrieval/verification, and sample management using a Lifecycle Approach and KNEAT.
- Design and develop cleaning procedures for new products and manufacturing equipment.
- Conduct cleaning validation studies, including sampling, testing, and data analysis.
- Investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents and deviations.
- Collaborate with cross-functional teams to integrate cleaning validation activities into the overall project plan.
- Train manufacturing and QC/QA personnel on cleaning validation documentation.
- Support the development of the periodic cleaning monitoring program.
- Benchmark against industry standards to achieve excellence in Cleaning Validation.
- Review and coordinate Change Controls with Cleaning Validation impact.
- Lead and support continuous improvement projects to eliminate waste and improve cleaning times through CIP Optimization.
- Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
Qualifications:
- Minimum of 8 years of experience in Cleaning Validation field execution.
- Proficient with KNEAT and CIP/SIP cycles.
- Demonstrated track record of leading and executing cleaning validation studies.
- Willingness to work non-traditional shifts, including nights, weekends, and holidays.
Desired Skills:
- Experience with project management and troubleshooting deviation CAPA change control management.
- Ability to support investigational studies as needed.
- Effective communication and collaboration skills to work across teams.
Pay Transparency: The typical base pay for this role across the U.S. is: $55.00 - $60.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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#AditiConsulting
# 26 - 01932
Salary : $55 - $60