Engineering Operations Manager Jobs in Massachusetts

The Operations Manager executes the implementation of the Critical Environment Cleaning Programs and ensures quality standard operating procedure adherence across the region.  Functioning closely with unit level managers and senior leaders to proactively support and sustain site-specific GMP cleaning requirements. Serve as the Subject Matter Expert for quality cleaning within controlled and regulated spaces. Reporting to the Regional Director.

Essential Duties and Responsibilities

Management of clean rooms operations, cleaning and operations in a clean room GMP regulated environment

Liaise with external and internal critical environment subject matter experts to promote best practices of the Critical Environment Cleaning program.
Establish audit program to monitor cleaning compliance throughout the region.
Collaborate with clients to develop customized cleaning solutions for quality controlled and regulated spaces.
Support customer audits & qualifications where necessary.
Supports RCA and CAPA responses related to GMP cleaning nonconformities is prefered 
Coordinate with Corporate QA team on new initiatives in GxP environments.
Train new and existing associates on GMP cleaning SOP's and cleanroom behaviors.
Incorporates latest best practices from organizations such as the Institute of Environmental Sciences and Technology (IEST), Food and Drug Administration (FDA), and international regulatory groups as needed into the Critical Environment Cleaning program.   
Provide regional support and participate in the mobilization of the Critical Environment Cleaning program.
Draft Critical Environment Cleaning related Monthly Business Review (MBR)/Quarterly Business Review (QBR) presentations and establish standardized client facing presentations.
Reviews and evaluates existing critical environmental quality cleaning programs, services, makes recommendations to operations team and/or client when requested and implements or guides implementation of new and/or modified systems and programs.
Has as a strong understanding of and works with company IT systems, utilizing appropriately and accurately.
Ensures Critical Environment Cleaning program compliance with Company Health, Safety, Security, & Environmental protocols, local building departments, and all other authorities having jurisdiction.
Prepares and maintains a variety of company records and reports as required. 
Other duties consistent with the role where required and/or requested by manager.

Lab Safety Duties

Must have a broad knowledge of EH&S principals and procedures.
Responsible for training others on lab safety requirements as required by the client. 
Recognition of potential work place hazards inside of a laboratory environment. 
Ability to mitigate safety hazards and perform work inside of a lab environment. 
Effectively communicate with other lab professionals to discuss policies and procedures related to safe lab operations.
Drive compliance of GMP standards in FDA regulated laboratories.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Financial experience include managing a P&L is required and managing fiscal and budgetary experience
Ability to communicate effectively in written format and oral presentations.
Ability to multitask and establish priorities.
Ability to maintain organization in a changing environment.
Exhibits initiative, responsibility, flexibility and leadership.
Analytical acuity.
Possess a thorough knowledge of contract administration and office procedures.
Ability to use working knowledge of work environment to meet established goals and objectives.
Ability to write reports, business correspondence, and procedure playbooks and manuals.  
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.