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.
- 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.
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.
