Senior Cleaning Validation Engineer (On-Floor Execution Lead) (JP15180)
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Job Location:
Holly Springs, MS - USA
Hourly Salary:
$ 55 - 65
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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.
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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone 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: $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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
