Job Title: Engineer, Cleaning Validation Specialist- (JP15151)
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: 03/19/26
Pay Rate: $44 - $47.50/hour W2
Notes: Only qualified candidates need apply. Standard Hours - hours may vary to support manufacturing (early/later shifts, possible weekends)
3 Key Consulting is hiring an
Engineer, Cleaning Validation Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:Our ideal Candidate: 5+ YOE with a B.S. in Science, Engineering, and Pharmacy areas.
This is a Cleaning Validation Specialist position. Candidate will coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.
- Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
- Supports non-traditional work schedule based on project and business needs
- Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
- Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
- Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
- Proficient with KNEAT execution
- Design and develop cleaning procedures for new products and manufacturing equipment.
- 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.
- Supports the periodic review of cleaning validation studies.
- 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.
Why is the Position Open?Planned Project
Top Must Have Skills:- Proficient with KNEAT or similar programs.
- Strong understanding of GMPs and global regulatory expectations.
- Ability to interpret equipment design, P&IDs, and process flow diagrams.
- Excellent technical writing and documentation skills.
- Strong analytical and problem solving abilities.
- Effective communication and cross-functional collaboration.
- Ability to work independently and manage multiple priorities.
Day to Day Responsibilities:Expectation is that the candidate will support execution and management of the CV lifecycle.
- Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
- Supports non-traditional work schedule based on project and business needs
- Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
- Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
- Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
- Proficient with KNEAT execution
- Design and develop cleaning procedures for new products and manufacturing equipment.
- 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.
- Supports the periodic review of cleaning validation studies.
- 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.
Basic Qualifications:Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience
Preferred Qualifications:Project Management experience.
Red Flags:Lack of experience on the floor or supporting field execution
Inability to support non-traditional work schedule
Interview process:
First round virtual screening 2nd round panel onsite.
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.