Cleaning Validation Coordinator

Job title: Cleaning Validation Coordinator

Contract:: 12 Months contract

Shift hours :: Shift Schedule: Fully Onsite - Monday – Friday 8:00 AM – 5:00 PM, 37.5 weekly hours.

Location: Whitchurch-Stouffville, ON L4A 0Y2

*Overtime is given after working beyond 38.75 ST hours.

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 Client site is required.