Process Specialist

Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Education: Bachelor
Experience: 0-3 Years
Salary:
Location: Mississauga, ON
Posted: October 9, 2019
Closes: November 9, 2019

Job description:

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 anemia, liver disease and organ preservation; and Evolve Biologics is dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.

Responsible for supporting the tech transfer, process design, equipment selection, process set-up and qualification, GMP document creation, and operator training for new client and internal projects. Provide technical leadership, training, troubleshooting of manufacturing operations.

MAJOR RESPONSIBILITIES:

Project Responsibilities:

  • Conduct Technical transfer activities of client and internal processes
  • Identify/prepare specifications for systems in project scope and support drafting of user requirement specifications
  • Review bids, design documents, quotations and functional specifications against user requirements, specifications and project budget
  • Review regulatory requirements (FDA, EMA, HC) for process systems and components against proposed systems.
  • Review system compliance to Environmental Health and Safety standards and regulations including HAZOP assessments and Pre-Start Health and Safety reviews.
  • Ensure compliance to project quality standards
  • Review supplier test specifications and test reports
  • Coordinate/Execute factory and site acceptance tests
  • Identify, investigate and resolve deviations from specifications
  • Support SOP/WIN drafting when required
  • Execute Commissioning, and IQ, OQ, PQ protocols
  • Train existing and new staff on process specific requirements
  • Support start-up, and engineering trials
  • Support completion of engineering trial lots
  • Interface with clients in support of project objectives
  • Generation and revision of 2D CAD drawings. Control and oversight of all project and facility drawings.

Production/Manufacturing Support:

  • Troubleshoot equipment and process problems
  • Identify and implement process improvements to achieve higher rates, yields and uptime
  • Prepare and present technical reports on manufacturing systems and processes
  • Support scale-up activities
  • Prepare and review SOP’s
  • Support Engineering drawings control process

Facilities Management:

  • Technical guidance/input on calibration program, CMMS, maintenance of engineering documentation.

EH&S:

Support company policy and applicable regulations

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE:

  • Engineering Degree and minimum 2-4 years’ experience.

PREFERRED QUALIFICATIONS:

  • Biochemistry or Bioprocess Engineering preferred
  • Experience in downstream purification
  • Experience in aseptic fill/finish
  • Experience in pharmaceutical environment
  • Knowledge of cGMPs and GAMP
  • CAD skills

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
  • This position requires vaccination for Hepatitis A and B
  • While we appreciate your 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 checks (for which a pardon has not been granted).

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 to Human Resources

Apply Now