Quality Engineering Specialist (40942)

Company Summary:

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Position Overview:

Germiphene Corporation, a Young Innovations company and a Health Canada-licensed manufacturer of dental pharmaceutical, natural health and medical device products, is hiring a Quality Engineering Specialist. Reporting to the Quality Manager, this role is the site owner of all Process Validation, Equipment Control, and Preventive Maintenance Programs, and keeps those programs in a state of continuous compliance with Health Canada GMP, ISO 13485 and regulatory requirements.

• You will own validation and qualification end to end: risk assessments, determining critical process parameters and acceptance criteria, drafting protocols and statistical sampling plans, directing protocol execution on the floor, interpretation of data, and finalizing reports.
• You will keep the site's equipment validation, calibration and preventive maintenance program in a state of compliance and are responsible for monitored systems, including the USP Purified Water System.

You’ll like this role if:

• You would rather propose the technical approach and defend it than wait to be handed a method.
• You like the discipline of validation work: define the parameter, prove the control, and write it up so it holds up three audits from now.
• You want to own programs rather than work a task queue.
• You can carry a concurrent portfolio of protocols, qualifications, change controls and CAPAs to agreed dates, coordinating work that depends on Production, Packaging, Maintenance, QC, Microbiology and R&D.
• You want the impact of your work to be visible. There is no separate validation or metrology group here, so the technical decisions and the programs are yours.

Why You’ll Love Working Here:

• Medium sized company, not too big, not too small, just enough to get things done and see your impact.
• Did we say benefits? Health, dental, and vision coverage; group RRSP; parental leave; statutory holidays; paid time off; short- and long-term disability insurance; employee assistance program; and more.
• Real ownership from day one. You are the site owner of validation, calibration and preventive maintenance: you set the technical approach, issue the protocols and reports, and your qualification decisions define how the equipment runs.

Who you’ll work with:

• You will report to the Quality Manager. The position has no direct reports and works daily across Production, Packaging, Maintenance, Quality Control, Microbiology, R&D and Regulatory Affairs at the Brantford site, as well as with Young Innovations corporate Quality counterparts at our sister facilities.

What You’ll Do:

• Validation and qualification
  • Own process validation under the Validation Master Plan: evaluate manufacturing processes to determine critical process parameters, develop protocols and acceptance criteria, apply statistical techniques to set sampling plans, manage execution on the floor, interpret the resulting data, and issue approved reports.
  • Lead risk assessments for process, equipment and cleaning validation, including process FMEA, and drive the resulting action plans.
  • Own equipment qualification for production and laboratory equipment (IQ, OQ, PQ), determine the extent of qualification required based on complexity and intended use, and set the critical operating parameters that follow from it.
  • Assist in the qualification and validation of computerized systems supporting production and laboratory equipment, including data integrity and user access verification, and maintain the qualified status of classified rooms through scheduled airflow and pressure differential verification.
  • Maintain the site's validation status and inventory: periodic review to confirm validations remain current and supported, revalidation decisions driven by change, deviation or trend, and retirement of validations that no longer apply through the document change process.
  • Monitor the ongoing state of control of validated processes, and support product development and production transfer by directing the validation work required to demonstrate a validated state.
• Calibration, preventive maintenance and equipment control
  • Own the site Calibration and Preventive Maintenance Programs through the calibration management system, including the equipment database, unique identifiers, master records, schedules, frequencies and tolerances.
  • Assess new equipment to determine whether calibration against traceable standards, performance verification against defined acceptance criteria, or preventive maintenance is the appropriate control.
  • Coordinate outside metrology and calibration services and review the resulting certificates and reports before equipment is returned to service.
  • Issue preventive maintenance work orders to Maintenance and system owners ahead of the scheduled date, record completed work, and coordinate HEPA filter certification and replacement for classified rooms, fume hoods and biological safety cabinets.
  • Maintain certified reference standards and metrology equipment, including certificates of conformance and traceability to a recognized national metrology institute.
  • Investigate calibration failures and out-of-tolerance results, assess impact on data and product generated since the previous event, and control equipment status including equipment out of service or removed from service.
• Monitored systems
  • Monitor the plant temperature and relative humidity systems and the USP Purified Water System: review monitoring data, test results and system parameters at the defined frequency, and respond to alarms and excursions.
  • Perform verification of water system pH, conductivity and total organic carbon instrumentation at the defined frequency.
  • Prepare trending and periodic performance reports for each system, including the annual review and trending of environmental monitoring data, and initiate investigation, deviation or corrective action where trends are adverse or results approach specification limits.
• Quality system, documentation and audits
  • Act as project manager for change controls and CAPAs you initiate or are assigned, driving each to closure: scope and impact, root cause, corrective and preventive actions, coordination across affected departments, and closure with supporting evidence.
  • Maintain the Validation Master Plan, and author and revise SOPs, forms and work instructions within your areas of responsibility, initiating document change requests and change controls as required.
  • Train and verify the competency of laboratory, production and maintenance personnel performing delegated calibration, monitoring and data collection activities, and confirm training is documented before the work is performed independently.
  • Present the validation, calibration, preventive maintenance and equipment programs in internal, customer and regulatory audits, and own the response to observations arising in those areas.

Qualifications

What You’ll Bring:

• Bachelor’s degree in engineering (mechanical, industrial, manufacturing, chemical or biomedical), chemistry, or related physical science discipline.
• Minimum five years of experience in quality, validation or metrology within a regulated manufacturing environment, including at least two years with direct responsibility for a validation, calibration or preventive maintenance program.
• Demonstrated experience independently authoring, executing and closing process, equipment and cleaning validation protocols and reports, including the development of statistical sampling plans.
• Demonstrated experience administering a computerized calibration and maintenance management system, including equipment records, scheduling, work order generation and calibration history.
• Working knowledge of Health Canada GMP (Food and Drugs Act, Division 2 and GUI-0001) and ISO 13485, and experience preparing for and participating in regulatory and customer audits.
• Understanding of metrology principles, including measurement traceability to national standards, calibration tolerance determination, and the distinction between calibration and performance verification.
• Ability to determine the technical approach to validation, qualification and investigation work independently, presenting a proposed methodology and recommendation for approval rather than requesting direction; analyses technical data, draws defensible conclusions, and reports results clearly in writing.
• Ability to organize and prioritize a concurrent portfolio of commitments with minimal supervision and deliver to agreed dates.
• Experience acting as CAPA owner and driving corrective actions to closure, and experience training and delegating technical work to laboratory, production or maintenance personnel, are preferred.

Technical Skills

• Hands-on experience with risk assessment tools, including process FMEA, and risk-based decision-making.
• Understanding of data integrity principles and regulatory requirements for computerized systems, including audit-trail and user access review.
• Proficiency with Word and Excel, and with project management tools such as MS Project or Smartsheet.
• Experience with pharmaceutical purified water systems (RO/EDI), including monitoring, sanitization and USP monograph compliance, is an asset (not required).

Travel Requirements

• Minimal. Occasional travel to supplier sites or sister Young Innovations facilities may be required.

Compensation Range: $80,000 – 90,000

The pay range reflects the minimum and maximum target for the position at the time of posting. Within the range, the compensation will be determined based on education/training, skill set, experience, and other organizational needs.

Work Environment

Manufacturing/Distribution Environment

This position operates in a pharmaceutical manufacturing environment. The role routinely involves working in or around manufacturing and laboratory areas, including machinery, equipment, and moving mechanical parts. The facility may be subject to varying temperatures, noise, and airborne particles such as dust or chemical fumes, depending on the area. PPE and gowning are required when entering production or QC areas. The role may require periods of standing, sitting, or walking throughout the workday. Occasional bending, lifting, or carrying items up to 23 kg may be necessary.

Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly required to sit. Hearing abilities required for this environment include being able to clearly hear and respond to audible alarms, production equipment, forklifts, and other machinery to maintain a safe work environment. Individuals must be able to distinguish and understand verbal communication including instructions, safety warnings, and team discussions, sometimes in an environment with moderate to high background noise.

In compliance with AODA legislation, if you require accommodation during any part of the recruitment process, please advise Human Resources.