Pharmaceutical Cleaning Validation Coordinator

Pay Range: $29.50hr - $34.50hr

Job Overview:

The candidate will be responsible for creating reports and protocols, supporting swab selection activities, and working on the floor to swab equipment associated with clinical studies. The successful candidate will perform various related responsibilities to support the organization's validation programs.

Responsibilities:

• Assist in the preparation, execution, and reporting of cleaning validation studies.
• Coordinate and 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 Quality Assurance, Quality Control, Operations, Engineering, and Manufacturing Science and Technology.
• Schedule cleaning validation studies around manufacturing activities.
• Support risk assessments, including FMEA, Risk Assessments, and 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.

Requirements:

• Bachelor's degree in Science, Engineering, Pharmacy, or a related discipline.
• 1+ to 2+ years of relevant experience, preferably in the pharmaceutical industry.
• Computer literate and proficient in Microsoft Word, Excel, PowerPoint, Adobe Reader, Outlook Applications, LIMS, Knowledge Tree, TrackWise, 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.
• Strong time management and organizational skills to multi-task and determine priorities.
• Ability to travel to other sites as required.

Due to nature of job The candidate must have Ability to work on the floor to swab equipment.