Cleaning Validation Coordinator

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:

1. 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.