Posted to MedZilla on 9/17/2019


Takeda Pharmaceuticals

US-MA, Facility Manager, Cell Therapies cGMP Facility R0009558-MZ


 
 

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

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

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.