Kaztronix
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Manufacturing Engineer,
Job Description
Manufacturing Engineer, Engineer & Validations
Oversees sterile filling, lyophalization and secondary packaging operations, and projects ensuring that a large number of highly complex pieces of process equipment and systems remain within their validated state and regulatory compliance.
Main Area of Responsibility:
Reliability engineering of process equipment and clean utility which includes:
Isolators/vial fill line
Lyophilizer and loader isolator
Powder filling machine
Automatic labelling machine
Secondary packaging (i.E Serialization / Aggregation)
WFI and clean steam generator
Overseas Retrofit and upgrade projects
Troubleshoot process equipment/sterile filling
Ensuring smooth operations of process and filling equipment
Other Area of Responsibility:
Plan and assess engineering challenges pertaining to policies, plans, and objectives
Work with Manufacturing, Validation, Facility, and Quality Control design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities
Plan and assess the need for system improvements in conjunction with Manufacturing, Facilities, Quality Assurance, Validation and Regulatory
Provide Re-Qualification support for process equipment
Provide equipment operational support, including being on call 24/7 (required)
Oversee all phases of the Change Control process for owned changes
Oversee timely closure of equipment related CAPAs
Oversee generation of all supporting documentation (scope documents;approval slides;work orders;protocols)
Provide peer review for all QA and Engineering documentation
Assess and plan for small process equipment projects
Project commissioning of equipment i.E. FAT / SAT / IOQ / PQ
Plan engineering standard practices that will result in consistent, reproducible documents
Oversee the creation of templates for URS as appropriate
Oversee the identification of equipment - specific best practices and performs gap analysis
Schedule estimates for the requirements of projects
Communicate project requirements to vendors to obtain proposals for equipment and piping changes
Plan, assess and oversee the execution of engineering tests and commissioning test plans
Review Qualification protocols
Troubleshoot and remediate exceptions during FAT/SAT/ IQ/OQ/PQ
Assess engineering project documentation
May assist project manager with large projects
Experience
B.S. In a related science field required;Chemical or Mechanical Engineering preferred
Minimum 3 years of experience in a cGMP Engineering environment
Minimum 3 years of experience in equipment design and oversight of installation
Project management skills to schedule, track progress, and make adjustments
Must be able to work in a fast-paced multi-disciplinary environment
Strong multi-tasking skills and effective at working in a dynamic environment with changing priorities
Experience in manufacturing area
Experience in Washers, Sterilizers, Lyophilizers, Depyrogenation Ovens, Filling Lines, and clean process utilities
Experience with disposable technology and in a cleanroom environment
Experience and training on industry standards for aseptic manufacturing engineering requirements
Proficient verbal, written and interpersonal communication skills with the ability to work with a team and direct the work of other team members
Strong knowledge of domestic and international cGMP regulations
Proficiency with Microsoft products;Proficient at learning additional software applications
Oversees sterile filling, lyophalization and secondary packaging operations, and projects ensuring that a large number of highly complex pieces of process equipment and systems remain within their validated state and regulatory compliance.
Main Area of Responsibility:
Reliability engineering of process equipment and clean utility which includes:
Isolators/vial fill line
Lyophilizer and loader isolator
Powder filling machine
Automatic labelling machine
Secondary packaging (i.E Serialization / Aggregation)
WFI and clean steam generator
Overseas Retrofit and upgrade projects
Troubleshoot process equipment/sterile filling
Ensuring smooth operations of process and filling equipment
Other Area of Responsibility:
Plan and assess engineering challenges pertaining to policies, plans, and objectives
Work with Manufacturing, Validation, Facility, and Quality Control design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities
Plan and assess the need for system improvements in conjunction with Manufacturing, Facilities, Quality Assurance, Validation and Regulatory
Provide Re-Qualification support for process equipment
Provide equipment operational support, including being on call 24/7 (required)
Oversee all phases of the Change Control process for owned changes
Oversee timely closure of equipment related CAPAs
Oversee generation of all supporting documentation (scope documents;approval slides;work orders;protocols)
Provide peer review for all QA and Engineering documentation
Assess and plan for small process equipment projects
Project commissioning of equipment i.E. FAT / SAT / IOQ / PQ
Plan engineering standard practices that will result in consistent, reproducible documents
Oversee the creation of templates for URS as appropriate
Oversee the identification of equipment - specific best practices and performs gap analysis
Schedule estimates for the requirements of projects
Communicate project requirements to vendors to obtain proposals for equipment and piping changes
Plan, assess and oversee the execution of engineering tests and commissioning test plans
Review Qualification protocols
Troubleshoot and remediate exceptions during FAT/SAT/ IQ/OQ/PQ
Assess engineering project documentation
May assist project manager with large projects
Experience
B.S. In a related science field required;Chemical or Mechanical Engineering preferred
Minimum 3 years of experience in a cGMP Engineering environment
Minimum 3 years of experience in equipment design and oversight of installation
Project management skills to schedule, track progress, and make adjustments
Must be able to work in a fast-paced multi-disciplinary environment
Strong multi-tasking skills and effective at working in a dynamic environment with changing priorities
Experience in manufacturing area
Experience in Washers, Sterilizers, Lyophilizers, Depyrogenation Ovens, Filling Lines, and clean process utilities
Experience with disposable technology and in a cleanroom environment
Experience and training on industry standards for aseptic manufacturing engineering requirements
Proficient verbal, written and interpersonal communication skills with the ability to work with a team and direct the work of other team members
Strong knowledge of domestic and international cGMP regulations
Proficiency with Microsoft products;Proficient at learning additional software applications
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