3 Key Consulting, Inc.

Engineer, Cleaning Validation Specialist- (JP15151)

3 Key Consulting, Inc.  •  $44 - $47.50/hr  •  Holly Springs, NC (Onsite)  •  2 months ago
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Job Description

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.


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.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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