Position Summary: The Facilities Engineer 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:- 2+ years of experience in Facilities/HVAC/utilities systems for a medical device of pharmaceutical company
- 2+ years of experience writing or executing validations
- Experience commissioning or validating a new facility is desired
- Experience working directly with the FDA is desired
- Must be a highly motivated leader ready to work in a fast-paced environment.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
The estimated base salary range for the Facilities Engineer role based in the United States of America is: $69,400 - $104,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
