Director Facilities & Engineering

 

JOB SUMMARY:

 

Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services to clients for the development, manufacture, purification, and packaging of therapeutic proteins. Facilities Manager has overall responsibilities for leading and directing the Facilities Department in accordance with established cGMP policies, procedures and objectives. Assist in the Validation requirements for all the base utilities to insure that licensing is achieved through the FDA or any other governing body.

 

 

 

MAJOR RESPONSIBILITIES:

 

  • Supervise, direct and co-ordinate activities of the Facilities & Engineering department including : calibration and maintenance, automation, production support and general building operations and support services.
  • Establish and monitor the facilities Budget and expenditures.
  • Ensure cGMP compliance of Preventative Maintenance and Calibration programs
  • Coordinate and interface with CAPEX programs
  • Plan for and detail plant shutdowns for scheduled repairs.
  • Monitor operations and maintenance of WFI USP water, Clean Steam, CIP, Bolier and Chiller Utility systems, Equipment and Fire Protection Systems.
  • Evaluate these operations for compliance with all Regulatory Bodies.
  • Contract negotiations for facility related services and related requirements.
  • Set standards for performance in Equipment PM’s and Calibrations.
  • Training in both safety and specialized equipment.

 

 

 

ADDITIONAL RESPONSIBILITIES:

 

  • Ensure Staff Training is current and up to date
  • Maintain SOP’s current and understood and updated if required.
  • Support IQ/OQ and PQ’s execution in a timely fashion and compliant.
  • Maintain ensure Engineering design documents library is current
  • Knowledge of AutoCAD

 

MINIMUM QUALIFICATIONS:

 

TECHNICAL KNOWLEDGE/EXPERIENCE:

 

  • Relevant Engineering degree  and 10|+ years of related experience in  a Biotech or Pharmaceutical environment
  • Leadership and problem solving skills         
  • Process experience in a dynamic setting.

 

BEHAVIORAL:  Demonstrated ability to apply the following behavioral competencies on the job:

 

Teamwork: Working effectively and productively with others.

Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives

Leadership: Achieving extraordinary business results through people.

Interpersonal Skills: Effectively communicating, building rapport and relating well to all kinds of people.

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

PREFERRED QUALIFICATIONS:

 

  • The knowledge of having hands on or field experience will create confidence in the direction of the maintenance crews and encourage a timely and positive work environment.                                                        

 

 

 

 

 

DOCUMENT APPROVAL

     
Head of the Department   Date
     
Hiring Manager   Date
     
______________________________________

Human Resources Department

  __________________________________________

Date

 

 

______________________________________            _________________________________________

Employee Print name and sign                                              Date

 

 

Success Stories

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