Job Title: Cleaning Validation Coordinator
Duration: 12+ Months
Schedule: Monday Friday | Fully Onsite
Hours: 8:00 AM 4:00 PM, 8:00 AM 5:00 PM, or 9:00 AM 5:00 PM
Weekly Hours: 37.5 hours plus applicable breaks
Pay Rate: $34.50 $43.13/hour, depending on experience
Position Overview
We are seeking a
Cleaning Validation Coordinator to support cleaning validation activities within a pharmaceutical manufacturing environment. The ideal candidate will have direct, hands-on experience with pharmaceutical cleaning validation and a strong understanding of GMP requirements.
This position will support the preparation, execution, documentation, and reporting of cleaning validation studies, including equipment swabbing, rinse sampling, data review, investigations, and validation documentation.
Candidates with strong relevant experience are encouraged to apply. The position is not intended to be highly senior-level, and candidates with the right technical foundation may be considered for training and development.
Key Responsibilities
- Assist in the preparation, execution, and reporting of cleaning validation studies.
- Coordinate and perform equipment swabbing and rinse sampling activities.
- Support swab selection activities.
- Work on the manufacturing floor to swab equipment associated with clinical studies.
- Support the collection, review, and organization of cleaning validation data.
- Evaluate cleaning validation results against established acceptance criteria.
- Support periodic reviews of cleaning validation programs.
- Prepare and revise validation protocols, reports, risk assessments, and related documentation.
- Ensure documentation complies with GMP, company procedures, and regulatory requirements.
- Support investigations related to cleaning validation deviations and excursions.
- Maintain validation files and ensure documentation is inspection-ready.
- Coordinate activities between QA, QC, Operations, Engineering, and MS&T.
- Schedule cleaning validation studies around manufacturing activities.
- Support FMEA, risk assessments, and gap assessments related to cleaning validation.
- Assist in identifying worst-case products and equipment locations.
- Support continuous improvement initiatives related to cleaning procedures and validation practices.
- Trend cleaning validation results and identify recurring issues.
- Participate in investigations, CAPAs, and change controls as required.
- Perform other related duties as assigned.
Required Qualifications
- Bachelor s degree in Science, Engineering, Pharmacy, or a related discipline.
- 1 2+ years of relevant experience, within the pharmaceutical industry.
- Direct experience with pharmaceutical cleaning validation.
- Experience working in a GMP-regulated environment.
- Understanding of cleaning validation principles and practices.
- Experience with cleaning validation protocols and execution.
- Experience with equipment swabbing and/or rinse sampling.
- Knowledge of acceptance criteria, residue limits, recovery studies, and worst-case assessments.
- Experience supporting cleaning validation investigations, deviations, and troubleshooting.
- Strong understanding of GMP/GLP regulations and regulatory requirements.
- Strong organizational and time-management skills with the ability to manage multiple priorities.
Preferred Qualifications
- Experience within pharmaceutical manufacturing.
- Solid Oral Dosage (SOD) experience.
- Quality Assurance, Quality Control, or quality-on-the-floor experience within a pharmaceutical environment.
- Pharmaceutical internship or project experience.
- Experience with manufacturing and packaging processes in a pharmaceutical environment.
- Familiarity with Health Canada, FDA, and EMA requirements.
- Knowledge of WHMIS and applicable safety precautions.
- Experience with LIMS, Knowledge Tree, TrackWise, and Veeva.
- Proficiency with Microsoft Word, Excel, PowerPoint, Adobe Reader, and Outlook.
- Ability to support activities at other company sites as required.
Key Technical Skills
The Successful Candidate Should Be Able To Demonstrate
- Direct, hands-on pharmaceutical cleaning validation experience.
- Knowledge of the scientific principles behind cleaning validation.
- Experience developing and/or executing cleaning validation protocols.
- Experience with swab and rinse sampling.
- Understanding of recovery studies and acceptance criteria.
- Knowledge of residue limits and worst-case assessments.
- Experience with cleaning validation investigations and deviations.
- Ability to explain the scientific rationale behind cleaning validation activities.
- Experience working within a pharmaceutical manufacturing or closely regulated environment.
Education & Experience Flexibility
Candidates who do not have the preferred degree may be considered if they possess substantial direct experience in:
- Cleaning validation
- Pharmaceutical manufacturing
- GMP environments
- Pharmaceutical internships or projects
- Quality or validation activities
Candidates with indirect, current, or previous involvement in a cleaning validation program may also be considered based on the overall strength of their experience.
Interview Process
- Initial interview via Microsoft Teams
- Onsite interview
