Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Facility Manager, Cell Therapies cGMP Facility R0007397-MZ


 
 

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Job Description

Position Title:

Facility Manager, Cell Therapies cGMP Facility

Function:

Global Real Estate and Facilities

Department:

Facilities

Reports To (Position Title):

Sr. Manager, Facilities

Written By:

Oscar Gomez-Sacasa

Date Written:

14-Jan-2019

Job Code:

Effective Date:

Location:

Cambridge, MA

OBJECTIVES: (Briefly summarise the overall purpose of the position. Objectives should

be written in 3 4 bulleted statements).

  • Responsible for the start-up, commissioning, turn-over and ongoing maintenance and operations of the physical building infrastructure for Cell Therapies cGMP facilities
  • Develops and implements maintenance, operation and calibration programs and standard operating procedures to ensure facility safety, reliability and compliance with Takeda quality polices and cGMP regulations
  • Plans and coordinates modifications to the facility and process equipment installation in the cGMP space
  • Provides oversight, coordination and governance to service providers to ensure on-time, on-budget and in-full delivery of services within the contract scope of work

ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified).

  • Leads facility turn-over activities from the construction team and supports process equipment installation, operational and process qualification
  • Develops and implements maintenance and calibration programs and SOP s for facility electrical, mechanical, HVAC, and process systems
  • Manages the building automation/management system including responding to and resolving alarm conditions
  • Coordinates with Landlord the timely maintenance and repairs to base building
  • Ensures certification and maintenance for fume hoods, BSC s and custom ventilated enclosures
  • Leads small non-capital and capital construction projects within the cGMP space
  • Responsible for implementing the calibration and maintenance management systems for the Cell Therapy facilities
  • Implements change management controls to ensure cGMP facility drawings are kept up to date
  • Along with EHS, participates in the Cell Therapy safety team
  • Supports Business Continuity Planning and Emergency Response
  • Responsible for facility regulatory compliance and inspection readiness including maintenance, calibration, cleaning and pest management programs

SCOPE OF SUPERVISION:

NUMBER SUPERVISED WORKERS

Direct

In-Direct

Employees

0-3

0

Non-Employees

0

0

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

  • Bachelor s degree in Engineering
  • Bio-pharmaceutical cGMP work experience
  • Strong verbal and written communication skills
  • Strong PC literacy with advanced skills in Microsoft Outlook, Word, Excel, and PowerPoint.
  • Excellent verbal and written communication skills
  • Expertise in working with real estate, facilities and procurement in a previous organisation is preferred

LICENSES/CERTIFICATIONS:

  • Certified Facility Manager (CFM) preferred

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

  • Able to stand for extended hours for test runs
  • Able to climb ladders/steps
  • Able to lift items of 25lbs

TRAVEL REQUIREMENTS:

  • Minimal travel as required for the work, primarily for meetings

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA

  • 3-5 years cGMP experience managing pharmaceutical manufacturing facilities

ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role

_________________________

Manager Approval (as required)

_________________________

Employee Signature (as required)

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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