Job Title: Cleaning Validation Coordinator
Duration: 12 months
Location: Stouffville, Ontario L4A1H5
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
- Minimum of 1 year Clinical experience within the pharmaceutical industry.
- Direct Cleaning Validation experience is the key requirement.
- Candidates with indirect/current/past involvement in a cleaning validation program may also be considered.
- Quality Control, Quality Assurance, or quality-on-the-floor experience within a pharmaceutical environment is beneficial.
- Solid Oral Dosage (SOD) experience is an added advantage, particularly given the nature of the site.
- 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.
