Cleaning Validation Coordinator

Job summary

Assist with planning, executing, and reporting cleaning validation studies, including equipment swabbing, rinse sampling, data review, and assessment of results against acceptance criteria. Prepare and maintain GMP-compliant validation documentation, support investigations and risk assessments, coordinate with site teams, and contribute to program reviews and continuous improvement.

Job details

Job: Cleaning Validation Coordinator Duration: 12 Months Location: Ontario, CAN Shift Schedule: Fully Onsite - Monday - Friday 8:00-4:00, 8:00-5:00, or 9:00-5:00, 37.5 weekly hours plus applicable breaks Job Description: Core essential skill sets: Bachelor's degree in Science or a related field. Flexibility: A candidate without the preferred degree or recent graduates could still be considered if they have substantial direct experience with: 1-2 years of relevant experience Cleaning validation Pharmaceutical manufacturing Pharma internship or project experience GMP Relevant quality/validation activities 2. Minimum of 1 year Clinical experience within the pharmaceutical industry. 3. Direct Cleaning Validation experience is the key requirement. 4. Candidates with indirect/current/past involvement in a cleaning validation program may also be considered. 5. Quality Control, Quality Assurance, or quality-on-the-floor experience within a pharmaceutical environment is beneficial. 6. Solid Oral Dosage (SOD) experience is an added advantage, particularly given the nature of the site. 7. GMP experience is acceptable; Health Canada experience is not mandatory. Candidates should have a general understanding of GMP regulations. Interview Process: Step 1: Initial interview will be conducted via Teams. Step 2: Onsite Day-to-Day Responsibilities - Creating reports and protocols. - Supporting swab selection activities. - Working on the floor to swab equipment associated with clinical studies. - Other related responsibilities outlined in the job description. Key Responsibilities and Primary Duties: Assist in the preparation, execution, and reporting of cleaning validation studies. Coordinate/perform equipment swabbing and rinse sampling activities. Support the collection, review, and organization of cleaning validation data. Assist in evaluating cleaning validation results against established acceptance criteria. Support periodic review of cleaning validation programs. Prepare and revise protocols, reports, risk assessments, and related validation documentation. Ensure documentation complies with GMP, company procedures, and regulatory requirements. Support investigation activities 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 risk assessments (FMEA, Risk Assessments, Gap Assessments) related to cleaning validation activities. Assist in identifying worst-case products and equipment locations. Support continuous improvement initiatives for cleaning procedures and validation practices. Help trend cleaning validation results and identify recurring issues. Maintain compliance with cGMP, Health Canada, FDA, EMA, and internal quality standards. Participate in investigations, CAPAs, and change controls as required. Other duties as required. Position Requirements: Bachelor’s degree in Science, Engineering, Pharmacy or related discipline. One (1) to Two (2) years of relevant experience, preferably in the pharmaceutical industry. Computer literate and proficient in: Microsoft Word, Excel, PowerPoint, Adobe Reader, Outlook Applications, LIMS, and Knowledge Tree, Track wise and Veeva. Working knowledge of GMP/GLP regulations and other Regulatory requirements for Canadian, US and EU markets, WHMIS, and Safety Precautions. Knowledge of Manufacturing and Packaging processes in a Pharmaceutical environment is preferred. Time management and organizational skills to multi-task and determine priorities. Some travel to other site is required.

What you’ll do

Assist with planning, executing, and reporting cleaning validation studies, including equipment swabbing, rinse sampling, data review, and assessment of results against acceptance criteria. Prepare and maintain GMP-compliant validation documentation, support investigations and risk assessments, coordinate with site teams, and contribute to program reviews and continuous improvement.

Requirements

A bachelor’s degree in science, engineering, pharmacy, or a related discipline is specified, with one to two years of relevant experience preferred and direct cleaning validation experience identified as key. Candidates should understand GMP and pharmaceutical manufacturing processes, be proficient with relevant office and quality systems, and have strong organizational and time-management skills.

Listed skills

• Quality assurance · Preferred
• Quality Control · Preferred
• Microsoft Office · Preferred
• Cross-Functional Coordination · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Cleaning Validation
• GMP Compliance
• Equipment Swabbing
• Rinse Sampling
• Validation Protocols And Reports
• Risk Assessments
• Deviation Investigations
• CAPA
• Change Control
• Data Review And Trending
• Pharmaceutical Manufacturing
• Quality Assurance
• Quality Control
• Microsoft Office
• LIMS
• Cross-Functional Coordination

Job areas

• Manufacturing
• Science & Research
• Healthcare
• Security & Safety

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