Engineer I, Controlled Environments

Getinge•Merrimack, NH

About The Position

The Quality Engineer I, Controlled Environments, provides engineering and technical support for cleanroom environmental monitoring, contamination controls, and microbiological testing. The role develops, revises, organizes, administers, and maintains compliance with routine controlled-environment efficacy programs, including systems qualification, environmental monitoring, and biological product testing. It also supports change control, CAPA activities, and other compliance work related to controlled environments and contamination control. The position supports the qualification and maintenance of routine testing programs for manufacturing environments used to produce medical devices. Work includes environmental and microbiological testing, trend analysis, risk assessments, standards compliance, controlled-environment qualification and requalification, technical documentation, investigations, and cross-functional projects involving manufacturing workflow, equipment relocation, and product-line changes. Duties are carried out in office and manufacturing/cleanroom environments, with some work potentially performed remotely.

Requirements

Bachelor's degree in Engineering, Biology, Microbiology, Chemistry, or a related science, and two years of experience in a medical-device or pharmaceutical environment; equivalent work experience may be accepted in place of education at the discretion of the Manager, CE&S.
Strong organization, negotiation, and communication skills.
Attention to detail and ability to self-review.
Familiarity with ISO standards for controlled environments and microbiological testing.
Ability to create and revise technical documentation and author position pieces with minimal guidance.
Education and experience sufficient to understand and comply with applicable U.S. and worldwide medical-device regulations.

Responsibilities

Develop, qualify, maintain, and analyze nonconformances for routine testing programs that ensure a manufacturing environment is suitable for medical-device production.
Conduct or oversee testing that includes air-pressure differential, temperature and relative humidity, air particulates, microbiological testing of systems and testing waters, biological air testing, surface bioburden, and compressed air and nitrogen testing.
Perform or oversee microbiological testing supporting sterilization assurance and contamination control, including bacterial endotoxin analysis of finished goods and in-process components and finished-goods bioburden analysis.
Oversee or perform sampling and manage the entry and review of controlled-environment and microbiological test results.
Maintain contamination-control, environmental-monitoring, and bacterial-endotoxin risk assessments.
Maintain conformance with applicable standards, conduct gap analyses for new or revised standards and guidance, and implement changes where applicable.
Represent CE&S on Operations and cross-functional projects involving manufacturing workflow optimization, equipment and work-stream relocations, and introduction or expansion of product lines.
Develop controlled-environment IQ/OQ/PQ protocols and reports to support facility and operational changes.
Maintain the controlled-environment requalification program, including generating protocols and reports.
Generate and own controlled-environment, contamination-control, and microbiological-testing CAPA requests and CAPAs; participate in cross-functional CAPAs as needed.
Write, implement, revise, and/or approve standard procedures, protocols, and reports related to controlled environments.
Author, ensure execution of, and approve microbiological test-method validations.
Develop controlled-environment and microbiological content and controls for equipment-relocation plans, part qualification, supplier-change assessments, and design-change quality plans.
Provide technical support for nonconformances and controlled-environment or product-testing excursions, including root-cause analysis and investigations.
Develop, maintain, and execute environmental and product microbiological testing trend-analysis programs.
Support additional departmental and special projects, and perform related duties as assigned.
Maintain compliance with quality requirements, applicable FDA and worldwide regulations, and required Quality & Compliance training; follow the company's Beyond Compliance Quality Culture.