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Facilities Engineer – Framingham, MA

Summary of job description:

The Facilities Engineer is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA manufacturing facility. The Facilities Engineer will provide routine engineering support for utilities, lab and manufacturing equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities for a select portion of equipment/utility portfolio serving as subject matter expert leading investigations relating to non-conformance events in partnership with Quality, Manufacturing and other departments.

 

Key responsibilities:

  • Provide direct engineering support for a portion of the site utility and equipment portfolio which includes clean utilities (Pure Steam, WFI, PW, Process Gases, etc.), HVAC systems, manufacturing process equipment and miscellaneous lab and support equipment.
  • Equipment ownership responsibility for the utilities, equipment and systems, which includes troubleshooting equipment to determine root cause of failure modes, owning corrective and preventative actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
  • Collaborate with cross-functional teams and/or lead investigations into equipment issues including technical writing of required quality documentation.
  • Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of construction, installation, start-up, commissioning and qualification of facilities and/or equipment.
  • Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.
  • Promote safety within the workplace by following site safety procedures, ensuring contractors are following safety requirements, performing proactive safety assessments, and fostering a safe work culture.

 

Other responsibilities

  • Support equipment and process related non-conformance investigations and change control activities.
  • Assist with internal and regulatory agency audits / inspections.
  • Support equipment validation and maintenance activities to ensure utilities and equipment remain compliant with required procedures and regulations.
  • Ensure training is kept in GMP compliant state.

 

Educational requirements:

  • BS in Chemical Engineering, Mechanical Engineering or similar

 

Experience and skill requirement:

  • A minimum of 3 years professional experience in engineering, facilities or operations.
  • A minimum of 1 year relevant experience in a cGMP environment is preferred.
  • Experience with GMP utilities and equipment is preferred.
  • Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are also important skills for this position.
  • Ability to work independently or in a team environment as well as being self-motivated and showing initiative.

 



EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.