Job Details

PROCESS SPECIALIST TECHNICAL SERVICES

Title
PROCESS SPECIALIST TECHNICAL SERVICES
Length
Full Time
Employer

Therapure Biopharma

Salary
not disclosed
Location
Mississauga
Ontario
Date Posted
16/05/2017 - 14:15
Closing Date
16/06/2017 - 14:15
Accepting BioReady
Yes
Job Description
Summary: 

Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.

We are growing! In fact, in 2014 & 2015, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.

The Technical Service Specialist is responsible for tech transfer assessment, technical services, providing training to operators, interacting with clients and completing internal projects. Troubleshoot during engineering runs and optimize process as required to meet customer’s specifications and internal quality requirements. Provide ongoing support to production through the project history as the process SME and support Project Management and Validation in the review/execution of process modifications. Excel to meet business standards and requirements by providing expertise in technical services. 

Education & Qualifications: 
  • Ideally a university degree in science or engineering would be preferred. A diploma in the field of science, engineering or technical studies would be accepted.
  • Hands on technical knowledge of small and large scale equipment would be an asset
  • Understanding of standard bioprocessing techniques (chromatography, UF/DF, filtration, nano-filtration, etc.)  Understanding of filling operations and equipment
  • Experience in a food/pharmaceutical manufacturing environment
  • Knowledge in cGMP and GMP
  • Proficient with Microsoft Office applications (i.e. Word, Excel, PowerPoint) 
Duties & Responsibilities: 
  • Participate in Technical transfer activities of client and internal processes
  • Work with clients, internal and external engineering to define, identify and source required process equipment  Ensure compliance to project quality standards
  • Ensure departmental compliance with established change control program requirements related to production activities and procedures.
  • Participate in factory and site acceptance tests
  • Identify, investigate and resolve deviations from specifications (engineering runs and production support as required)
  • Assist Lead Hand Tech Services in maintaining project history file and help produce a handover package for production
  • Prepare draft BPR’s and SOP’s; provide review when necessary as process SME
  • Commissioning and Validation support including execution of IQ, OQ, PQ protocols
  • Train existing and new staff on process specific requirements
  • Support start-up, and engineering trials. This will require shift work (i.e. day, afternoon and midnight) as necessary based on project schedule.
  • Provide technical support for production during the initial manufacture of production lots and ongoing support as the SME as required
  • Work with OEM, internal departments and clients for process troubleshooting as required.
  • Identify and implement process improvements/optimizations to achieve higher rates, yields and uptime
  • Prepare and present technical reports on manufacturing systems and processesSupport scale-up activities  Participate in Risk Assessment activities including Hazard and Operability Studies (HAZOP)
  • Review system compliance to Environmental Health and Safety standards and regulations
  • Perform process and EH&S risk assessment for project change activities
  • Present project updates and ideas to department members
  • Perform other duties as assigned
  • Coordinate with other departments and consultants for validation activities
  • Support initiation, actions and closure of Change Requests and CAPAs, as required 
Other Information: 

Interested candidates can send their resume and cover letter to talent@therapurebio.com. Please reference the PROCESS SPECIALIST in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.

Therapure BioPharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure BioPharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure BioPharma Inc. Human Resources team.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources at HR@therapurebio.com for assistance.

Key Words: pharmaceutical, scale-up, therapure, biopharma, technical support, specialist