Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)
Company: 3 Key Consulting
Location: Holly Springs
Posted on: April 2, 2026
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Job Description:
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: $60 - $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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Cary , Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180), Engineering , Holly Springs, North Carolina
