Infotree Global Solutions

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Added 14 hours ago
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Closed listing

Infotree Global Solutions

Cleaning Validation Coordinator

Whitchurch-Stouffville, ON, Canada

Contract

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Job type: Contract
Closing date: Oct 23, 2026
Posting language: English
Posted: Sep 23, 2026

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Original job description

Archived listing. The details below describe a past opening.

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.

About employer

More about this job

Responsibilities

Assist with planning, executing, and reporting cleaning validation studies, including equipment swabbing, rinse sampling, data review, and assessment of results. Prepare and maintain validation documentation, coordinate cross-functional activities, support investigations and risk assessments, and help improve cleaning validation programs.

Requirements

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

Skills

Cleaning Validation
GMP Compliance
Pharmaceutical Manufacturing
Equipment Swabbing
Rinse Sampling
Validation Protocols and Reports
Risk Assessment
Data Review and Trending
Deviation Investigations
CAPA
Change Control
Quality Assurance
Quality Control
Solid Oral Dosage
Microsoft Office
LIMS

Visa sponsorship

Not detected in the job text

Keywords

Cleaning Validation
Pharmaceutical Manufacturing
GMP
cGMP
GLP
Equipment Swabbing
Rinse Sampling
Validation Studies
Validation Protocols
Validation Reports
Risk Assessment
FMEA
Gap Assessment
Acceptance Criteria
Worst-Case Products
Quality Assurance
Quality Control
Clinical Studies
Solid Oral Dosage
Deviation Investigation
CAPA
Change Control
LIMS
Knowledge Tree
TrackWise
Veeva
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Health Canada

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