Sr. Validation Engineer (Cleaning Validation)

Infotree Global Solutions; Holly Springs (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading global solutions provider is seeking a Cleaning Validation Specialist located in Holly Springs, North Carolina. The role requires extensive experience in executing cleaning validation studies and managing related activities. Responsibilities include leading validation efforts, developing cleaning procedures, and collaborating with cross-functional teams. Candidates should be proficient with KNEAT and able to work non-traditional shifts. A strong educational background and communication skills are essential for success in this position.

Qualifications

• Doctorate degree or equivalent experience.
• 8+ years of experience in cleaning validation execution.
• Ability to work non-traditional shifts as needed.

Responsibilities

• Lead all Cleaning Validation activities including protocol generation and data verification.
• Design and develop cleaning procedures for new products.
• Conduct cleaning validation studies and troubleshooting.

Skills

Proficient with KNEAT

Effective communication and collaboration skills

Track record of leading cleaning validation studies

Proficient with CIP/SIP cycles

Demonstrated proficiency in utilizing PI for run trending analysis

Education

Doctorate degree

Masters degree and 2 years of experience

Bachelors degree and 4 years of experience

Associates degree and 8 years of experience

High school diploma / GED and 10 years of experience

Tools

Kneat

Process Improvement tools

Job description

Fully onsite - 8-5 Monday - Friday - occasional availability needed outside normal hours such as nights or weekends.

Ideal candidate: 8+ YOE Must have field execution experience.

• Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, sample management following a Lifecycle Approach and using Kneat.
• Supports non-traditional work schedule based on project and business needs
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.
• Support the development of the periodic cleaning monitoring program.
• Benchmark against the broader Client network and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.
• Support assigned teams as required to provide Cleaning Validation guidance.
• Review and coordinate Change Controls with Cleaning Validation impact as required.
• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times through CIP Optimization.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Top Must Have Skill Sets:

• Proficient with KNEAT
• Demonstrated track record of leading and executing cleaning validation studies and knowledge of CV lifecycle
• Proficient with CIP/SIP cycles and process understanding to drive execution of validation deliverables
• Willingness to work non-traditional shift, off shift, weekends, and holidays to support cleaning validation activities as needed
• Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
• Effective communication and collaboration skills to work across teams.
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Nice to have: PM experience, troubleshooting deviation CAPA change control management, ability to support investigational studies as needed.