Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)

Job Title: Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)

Location: Holly Springs, NC. 27540

Employment Type: Contract

Business Unit: NPI and MFG Systems

Duration: 1+ year (with likely extensions and/or conversion to permanent)

Posting Date: 03/26/26

Pay Rate: $55 - $65/hour W2

Notes: Only qualified candidates need apply. Fully onsite - 8-5 Monday - Friday - occasional availability needed outside normal hours such as nights or weekends.

3 Key Consulting is hiring a Senior Cleaning Validation Engineer (On-Floor Execution Lead) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Our ideal candidate will have 8+ YOE and 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 internal 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

Why is the Position Open?

Planned Project

Top Must Have Skills:

• 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.
• Field execution experience
• Nice to have: PM experience, troubleshooting deviation CAPA change control management, ability to support investigational studies as needed.

Day to Day Responsibilities:

See job description above.

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

Red Flags:

• No track record of field execution and managing high-volume of validation deliverables
• Not willing to support non-traditional work hours
• Not familiar with KNEAT

Interview process:

1st virtual initial screening, 2 panel interviews (in-person) which will take place same day.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.