Laboratory Systems Configuration Management Lead
Cambridge, MA

Job Description

ABOUT FOUNDATION MEDICINE:

Foundation Medicine, Inc. (FMI) began with an idea-to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

ABOUT THE JOB:

Laboratory Systems Configuration Management Lead is responsible for ensuring effective and efficient configuration management procedures are applied in FMI's automated clinical laboratory environments. This incumbent provides continuous development and operational excellence initiatives involving automated laboratory equipment and systems in a complex and rapidly advancing space. The set of instrumentation supported by the Lead includes liquid handlers, robotic manipulators, bulk reagent dispensers, microplate readers, and supporting software systems. This candidate will work closely with the Process Engineering, Laboratory Automation, Product Development, Operations, Quality, and Regulatory Teams to ensure that activities involving the introduction and operational management of new or updated automated solutions into our clinical laboratory environments are done so in accordance with the appropriate FMI Quality, Regulatory, and Security policies. This position requires working in a lab environment using chemicals and regents.

Key Responsibilities:

* Facilitate the creation, editing, and periodic review of requisite documentation involved in software and hardware configuration management according to Foundation Medicine Incorporated's Quality and Regulatory Policies.
* Support configuration management activities for a variety of automated laboratory systems which include reporting, auditing, qualifying, and documenting by maintaining a dynamic database for all production software and hardware configurations.
* Interface with a variety of enterprise systems including, but not limited to: IBM Maximo, Master Control, SharePoint, Git, Confluence, JIRA, and IQVIA Pilgrim EQMS.
* Facilitate regular interval communications with all software and hardware stakeholders to ensure laboratory system configurations efficiently and effectively meet our overall business goals and regulatory requirements.
* Lead and participate in cross-functional projects supporting enhancements to existing and newly developed automated laboratory assays and workflows.
* Support the development, installation, qualification, and version control of automated protocols on applicable instrumentation across our global laboratory facilities.
* Provide subject matter expertise, training, documentation, and technical recommendations for new or existing team members to implement best practices for configuration management throughout the applicable systems lifecycle.
* Work with multiple teams to develop tools, processes, best practices and associated documentation to support current and future configuration management activities and compliance requirements.
* Review required documentation for engineering releases and production qualifications by verifying that all configuration management related requirements have been met.
* Additional responsibilities as assigned.

QUALIFICATIONS:

Basic Qualifications:

* Bachelor's Degree.
* 7 years of experience developing computer-related technology within a pharmaceutical, biotechnology, life science or diagnostic laboratory setting.

Preferred Qualifications:

* Advanced Degree in any of the following disciplines: Biotechnology, Chemistry, life science or computer-related technology.
* Quality Management experience.
* Strong experience working in the software and/or hardware configuration management specialty in a pharmaceutical, biotechnology or diagnostic laboratory.
* Demonstrated experience with enterprise level configuration management supporting quality software systems, including:
* IBM Maximo
* Master Control
* Git
* Confluence
* JIRA
* SharePoint
* IQVIA Pilgrim EQMS


* Strong familiarity with automated laboratory equipment commonly used in diagnostic, bioprocess, manufacturing or other laboratory-based industries with regulated quality standards.
* Previous experience working in a regulated molecular diagnostics and clinical laboratory setting adhering to requirements established in Food and Drug Administration - Quality System Regulations, European Union, Clinical Laboratory Improvement Amendments, College of American Pathologists, Good Clinical Practices, and International Organization for Standardization.
* Demonstrated ability successfully document and report configuration management states to support periodic review and internal or external audits.
* Ability to produce technical documentation in Microsoft Office Suite, particularly Word, Excel, PowerPoint.
* Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues.
* Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow.
* Demonstrated ability to meet project deadlines.
* Understanding of HIPAA and importance of privacy of patient data.
* Ability to work well under pressure while maintaining a professional demeanor.
* Excellent organization and attention to detail.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.