Filling Specialist

BioTalent Canada; Cambridge; On-site; CAD 42,000 - 65,000; Full time

Job summary

Septodont in Cambridge, Ontario seeks a Filling Specialist to support filling room operations in a GMP environment. You will be responsible for line changeovers, machine setup, aseptic practices, and in-process quality checks, while maintaining gowning certification and adhering to cleaning standards.

The role emphasizes troubleshooting, equipment maintenance, and collaboration with production and maintenance teams to ensure efficient manufacturing and compliance with regulatory requirements.

Qualifications

• Must be gown certified with strong gowning techniques.
• Good documentation practices.
• Meets expectations on most recent Performance Appraisal.
• Demonstrated mechanical aptitude.
• Troubleshooting experience.
• Willing to work extra hours.
• Training experience of others is preferred.

Responsibilities

• Responsible for line changeovers, sanitization, cleaning of the lines.
• Sets-up and disassembles the filling machines.
• Models all Aseptic practices and behavior while involved in Aseptic processes.
• Understands the first air principal to avoid cross contamination of products and their components.
• Understands basic Microbiology.
• Follows proper cleaning and sanitization techniques.
• Maintains annual Gowning Certification.
• Performs filling in-process quality checks as required.
• Performs troubleshooting and minor adjustments and interventions on the filling machines.
• Provides preventative maintenance support on the filling machines.
• Reports any problems of production equipment to Lead Hand / Supervisor of area.
• Reports and works with the Production Supervisor and maintenance to resolve production/ equipment problems.
• Provides direction and oversight to operators in filling room or adjacent supporting areas.
• Steps into Lead Hand role in absence of area Lead Hand.
• Trains new filling room operators on filling machine operation.
• Participates in Overall Equipment Efficiency.
• Communicates the need for any filling room supplies and tools that are required to run production efficiently.
• Follows GMP and regulatory compliance requirements, and ensures quality standards are met.
• Updates Standard Operating Procedures and executes employee training.
• Assists with MDI and DIR Investigations.
• Performs activities in the moment, under scrutiny from many departments and by the client.
• Observes and supports all safety guidelines and regulations.
• Demonstrates the Company Mission, Vision and Values Statements, policies and current standard business practices.
• Performs other related duties as required.

Skills

Gowning techniques

Documentation practices

Troubleshooting

Mechanical aptitude

Training others

Overtime willingness

Education

High school diploma

Job description

Present in more than 110 countries, the Group relies on the energy, expertise, and passion of 2,600 employees. With 6 international production sites, Septodont combines industrial excellence, technological expertise, and innovation to meet the needs of healthcare professionals worldwide.

In North America, our operations include facilities in Ontario, Quebec, and Pennsylvania. Our Cambridge, Ontario site is home to Novocol Pharma – a thriving center of innovation with over 40 years of expertise in sterile injectable cartridges and combination product manufacturing. Backed by a team of more than 675 dedicated professionals and modern facilities, we deliver high-quality, customer-focused solutions to partners around the world.

Beyond our expertise, our people are our greatest strength. We foster a stimulating work environment where everyone can learn, grow, and build a career that reflects their aspirations, supported by continuous training and internal mobility. As a socially responsible company, we place diversity and inclusion at the heart of our development, convinced that they enhance collective performance and foster human experience.

Joining Septodont means becoming part of a human-scale international group and contributing to a meaningful mission: improving health for as many people as possible. What if your next professional chapter started with us?

FUNCTION SUMMARY:

The Filling Specialist is accountable to the Production Supervisor for all activities performed in the Filling Rooms in a manner that ensures all activities are efficient, effective and in accordance with the requirements outlined in Standard Operating Procedures and Good Manufacturing Practices.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Responsible for line changeovers, sanitization, cleaning of the lines
• Sets-up and disassembles the filling machines
• Models all Aseptic practices and behavior while involved in Aseptic processes
• Understands the first air principal to avoid cross contamination of products and their components
• Understands basic Microbiology
• Follows proper cleaning and sanitization techniques
• Maintains annual Gowning Certification
• Performs filling in-process quality checks as required
• Performs troubleshooting and minor adjustments and interventions on the filling machines
• Provides preventative maintenance support on the filling machines
• Reports any problems of production equipment to Lead Hand / Supervisor of area
• Reports and works with the Production Supervisor and maintenance to resolve production/ equipment problems
• Provides direction and oversight to operators in filling room or adjacent supporting areas
• Steps into Lead Hand role in absence of area Lead Hand
• Trains new filling room operators on filling machine operation.
• Participates in Overall Equipment Efficiency
• Communicates the need for any filling room supplies and tools that are required to run production efficiently
• Follows GMP and regulatory compliance requirements, and ensures quality standards are met
• Updates Standard Operating Procedures and executes employee training
• Assists with MDI and DIR Investigations
• Performs activities in the moment, under scrutiny from many departments and by the client
• Observes and supports all safety guidelines and regulations
• Demonstrates the Company Mission, Vision and Values Statements, policies and current standard business practices
• Performs other related duties as required

BASIC REQUIREMENTS:

Education

• High school diploma

Experience

• Must be gown certified with strong gowning techniques.
• Good documentation practices
• Meets expectations on most recent Performance Appraisal
• Demonstrated mechanical aptitude
• Troubleshooting experience
• Willing to work extra hours
• Training experience of others is preferred

Work Authorization: Applicants must be legally authorized to work in the country where the position is based for the duration of employment. This position is not eligible for employer-sponsored immigration support.

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.