Description:
The Facilities Engineer 1 will be responsible for developing and executing validation protocols as related to new or upgraded facilities and utilities as used for medical device manufacturing. This person will work cross-functionally to assist with the development of requirements based on their expertise in clean rooms, water systems, HVAC and other systems used to support a regulated manufacturing environment. This person will also be responsible for report writing.
Responsibilities
- Work cross functionally to develop and execute validation plans
- Generation of design specifications as well as other engineering-related documentation to support facility / utility qualifications and commissioning
- Preparation and execution of protocols for validation of HVAC, environmental monitoring, utilities, clean rooms, and cold storage
- Develop and defend rationale for protocol design, sampling requirement, and acceptance criteria using industry accepted standards
- Compile and analyze validation data and prepare reports
- Investigate and troubleshoot problems which occur during qualification and determine solutions
- Assess impact of change control to qualified systems to ensure a state of compliance is maintained
- Develop and coordinate schedules in conjunction with the other functional groups and vendors
- Lead continuous improvement and sustaining efforts to improve effectiveness of validation procedures
- Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels
- Foundational understanding and practical experience with FDA cGMP regulations and requirements for facilities and utilities for medical device manufacturing.
- Establish and maintain cross functional relationships with manufacturing, engineering, quality control, development and regulatory for validation optimization and support of a successful facility validation program.
- Experience with sustaining and validation of environmental monitoring and control systems (BMS / EMS)
- Ability to manage competing priorities/projects and maintain tight timelines
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements
- Typically Requires a minimum of 0-2 years of related experience with a bachelor’s degree or technical schooling; or a master’s degree; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls.
- Some knowledge of clean rooms, RODI, HVAC and other systems used to support a regulated manufacturing environment
- Experience creating master validation plans, protocols, and reports
- Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook
- Ability to read construction drawings and blueprints
- Demonstrated analytical and problem-solving skills
- Strong oral and written communication skills
- Good design, research, writing and verbal communication skills.