Validation Associate

About Resolute

Resolute Workforce Solutions, a staff augmentation subsidiary of Brevitas Consulting Inc., provides qualified professionals to support the workforce requirements of organizations in the pharmaceutical and life sciences sectors.

We have been retained by a pharmaceutical manufacturing company to support its increased production demands through the provision of qualified resources at its manufacturing facility in Brantford, Ontario. All positions associated with this engagement are site-based and require personnel to work on-site. Please review the site location and associated logistics, including commuting arrangements, accessibility, and any site-specific requirements, when considering these opportunities.

Role Overview

We are looking for a highly motivated and energetic professional to join our team as a Validation Associate in Brantford, ON (Onsite). This role has a significant potential to extend to 1 year.

Responsibilities:

• Provide Quality support for New Product Development (NPD) and Existing Product Development (EPD) projects, including cleaning validation activities.
  
• Develop validation protocols and final reports for equipment, facility, cleaning, process, and computerized system qualifications.
  
• Maintain and update the Master Validation/Qualification Plan and manage calibration and preventive maintenance programs, coordinating with contractors to ensure compliance.
  
• Develop and implement SOPs and support the review and approval of QMS documents, including deviations, change controls, CAPAs, complaint investigations, and training records.
  
• Coordinate regularly with Production and QA teams to support operational planning and activities.
  
• Assist in preparing validation-related sections of Annual Product Quality Reports (APQRs).
  
• Follow all Occupational Health and Safety Act requirements, regulations, and safety procedures, and perform other duties as assigned by the Associate Manager, Quality.
  

Qualifications:

• Bachelor's degree in Science, Engineering, or a related field from an accredited university; Master's degree preferred.
  
• Minimum 5 years of experience in Quality Engineering, QA/QC, or Validation within a pharmaceutical manufacturing GMP/cGMP environment.
  
• Certified Quality Engineer (CQE) certification is an asset. Experience with GC, HPLC, laboratory equipment, and microbiological testing is preferred.
  
• Thorough knowledge of GMP/cGMP, GLP, regulatory standards, and proficiency in MS Word, MS Excel, and electronic systems.
  
• Strong organizational, time management, multitasking, and problem-solving skills, with the ability to manage high workloads, work under pressure, and drive continuous improvement.
  
• Excellent interpersonal, verbal, and written communication skills, with good judgment and the ability to collaborate effectively with internal teams and external contacts.
  
• Overtime may be required based on production needs and must be approved by Management.
  

Note:Theannualsalaryrangeis$55,000–$65,000,dependingonqualificationsandexperience.