Sterile Manufacturing Equipment Maintenance & Validation Engineer
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Job Location:
Mississauga - Canada
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
We are hiring a Sterile Manufacturing Equipment Maintenance & Validation Engineer to own hands-on technical support for aseptic fill-finish operations (bottle filling and IV bag filling) and to lead execution of cleanroom routine maintenance and validation/requalification activities. You will drive equipment reliability reduce downtime and maintain a strong state of control in a regulated environment.
What you will do:
Aseptic processing equipment ownership
- Troubleshoot repair and maintain complex aseptic filling equipment for bottles and IV bags (mechanical electrical pneumatic instrumentation and controls).
- Diagnose faults using drawings/schematics OEM documentation alarms trending and systematic root-cause methods.
- Own PM strategy and execution: PM plans job plans lubrication/inspection standards calibration coordination and critical spares.
- Lead reliability improvements: repeat-failure elimination downtime tracking and corrective action effectiveness checks.
- Coordinate OEM/vendor service and support: scope work supervise execution and verify outcomes.
Cleanroom maintenance and validation/requalification
- Execute and maintain the site plan for cleanroom routine maintenance and periodic requalification activities in support of aseptic operations.
- Lead qualification/validation deliverables tied to equipment and controlled environments (IQ/OQ/PQ execution support protocols reports and traceable evidence).
- Support change control impact assessments for equipment components recipes/settings and maintenance changes.
- Coordinate and support cleanroom certification activities (e.g. HEPA integrity testing airflow visualization particle mapping pressure differential verification) and maintain documentation packages.
Quality and compliance
- Support deviations investigations and CAPAs with strong root-cause analysis and clear technical documentation.
- Update and create SOPs/work instructions for maintenance setup checks and controlled-environment activities.
- Support internal and external audits/inspections by providing objective evidence and technical explanations.
Qualifications :
- 5 years in a regulated manufacturing environment (pharma/biotech/medical device preferred) supporting complex production equipment.
- Demonstrated hands-on troubleshooting across mechanical electrical and controls domains.
- Experience executing qualification/validation work (not only reviewing) including protocol execution and report writing.
- Strong documentation practices and comfort working under GMP expectations.
- Willingness to work in cleanrooms and support planned shutdown windows; ability to support on-call or off-shift work as needed.
Preferred qualifications:
- Experience in aseptic fill-finish equipment (bottle filling IV bag filling sterile transfer systems RABS/isolators).
- Exposure to PLC/HMI troubleshooting instrumentation and sensor tuning.
- Experience coordinating cleanroom certification providers and interpreting results/trends.
What success looks like:
- Reduced unplanned downtime and repeat failures on aseptic filling lines.
- Clear practical PM system with high schedule compliance and effective spare parts strategy.
- Cleanroom and equipment qualification activities executed on time with complete audit-ready documentation.
- Fast structured response to issues with strong root-cause and durable fixes.
Additional Information :
We thank all applicants for their interest in this position with Traferox Technologies Inc. Please note that only candidates selected for an interview will be contacted.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
The University Health Network, where above all else the needs of patients come first, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, t ... View more
