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Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)
Holly Springs, NC · Biotech/PharmaceuticalJob 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: $65 - $70/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.
Why is the Position Open?
Planned Project
Top Must Have Skills:
Day to Day Responsibilities:
See job description above.
Basic Qualifications:
Red Flags:
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.
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: $65 - $70/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.
Regards,
3KC Talent Acquisition Team