Job Title: Process Engineer
Summary: The process engineer is responsible for the installation, qualification, operation, supervision of a biomedical device assembly facility clean room. The role includes developing standard operating protocols, training materials, scheduling, and reporting activities for manufacturing within a regulatory controlled environment. This includes operations of the facility, electrical, process equipment , HVAC, high performance air filtering, and cleaning.
The process engineer is responsible for handling multiple projects for the lifecycle of the controlled environment including commissioning and qualifications activities to decommissioning. He or she will be responsible for organizing, budgeting, scheduling, carrying out, instruction, and supervision of the project as directed by company leadership.
Company Overview: Hibernicor is an innovative medical device company that manufactures single use disposable containers which will be marketed for sale in the US and Europe.
Key Position Responsibilities:
The process engineer will be responsible for defining the critical quality attributes, and process parameters in the clean room including particulate levels, relative humidity, and temperature parameters in a GMP compliant manner. The engineer should define the clean room requirements in a user requirements document and solicit input from qualified vendors following established ISPE/ASTM methodologies and guidance.
The process engineer will perform and maintain a risk assessment for all the critical process parameters including quality assurance, quality control, commissioning, validation, manufacturing safety, automation, and project management. This may include researching, developing and acting on plans using in depth knowledge of ISO and 21 CFR Part 11 and other regulatory guidelines.
The process engineer will prepare commissioning and qualification protocols, standard operating procedures, and work instructions as needed for equipment and facility operations aligning with an overall master validation plan. The engineer should be able to write the validation master plan, commissioning and validation documents for the clean room, HVAC systems, and equipment; specifically design qualification, installation qualification, operational qualification, and procedure qualification documents (DQ/IQ/OQ/PQ). The engineer should be able to prepare checklist and complete inspections that includes both static and dynamic exhaustive testing of systems or major system components to support the qualification of equipment or system based upon manufactures acceptance test or user requirements specifications (FAT/SAT).
The process engineer must of have experience and understanding of clean room facility and requirements. In addition the engineer must have knowledge of computer system validation requirement and preparation and execution of protocol related to computerized systems provided by vendors. The engineer will supervise with the help of contractors on daily basis with follow up and completion of qualifying activities and GMP documentation including: clean room fitment, filter, HVAC and software automation testing and audit trail verifications.
The process engineer will supervise progress of the commissioning and qualifying activities on a periodic basis and hold status meetings with the stakeholders. The engineer will maintain alignment to the budgetary guidelines, quality and safety standards. The engineer will need to maintain and update quality control documents in an existing electronic GMP compliant document management system.
The process engineer will need to manage multiple task to coordinate projects timelines and work collaboratively with vendors and stakeholders to mitigate risk, facilitate problem solving, and to reduce or avoid delays.
Minimum employee qualifications:
Bachelor degree in engineering or science field
US citizen or permanent resident
A minimum of 3 years of professional experience leading, initiating and completing projects.
Experience with statistical data and an ability to effectively perform technical analysis
Experience making risk based decisions
Experience navigating and adhering to structured system requirements (i.e. Quality Management System)
Demonstrated effective communication of technical information, both verbally and in written reports
Ability and willingness to respond beyond normal business hours (including weekends).
Desired position skills in:
Working in a clean room environment and understanding facility infrastructure, as it relates to supporting a clean room.
Working knowledge of environmental standards (FDA 21 CFR Part 11, ISO 14644, ISO 14698, etc.)
Understanding of bioburden, endotoxins, particulate, etc. and conducting statistical analysis thereof.
Reporting: The packaging engineer reports to the quality manager and company director.
Location: The location of the job is at the company offices either in the US. If travel may be necessary to accomplish the job responsibilities and is anticipated to be no more than 10% of the employment.
Type of Employment: The position is full time.
Salary Range & Benefits: The salary and benefits are commensurate with the applicant’s qualifications and experience.
How to Apply: Please submit a cover letter, resume and 3 references with contact information. We will respond to suitable candidates by email to setup an initial telephone interview.
Contact Information:
HIBERNICOR LLC
253 Ridge Drive
Jackson, MS 39216
Email: