Commissioning & Qualification (C&Q) Specialist Engineering
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.
Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins. The C&Q Specialist will be responsible for and oversee the Commissioning and Qualification efforts related to the execution and implementation of Engineering projects. The role includes the development of robust systems to enhance and expedite qualification related activities and to influence appropriate validation precursors. The position is accountable to support all Commissioning and Qualification activities relating to clinical and commercial manufacturing and related issues which directly or indirectly impact product quality. The main focus and responsibility of this position is to provide effective leadership and oversight to the C&Q program which directly impacts the regulatory compliance status of engineering related projects.
Here is what we are looking for:
- University degree in Engineering or Science.
- Minimum 4 years of direct Commissioning/Qualification/Validation/QA experience in Pharmaceutical or Biotech environment
- Knowledge and understanding of cGMPs, aseptic processing standards and biopharmaceutical industry guidelines
- Proven ability to influence others and foster collaboration
- Must have strong organizational, presentation and technical writing skills Successful performance in leading multiple projects
Here is what you will be responsible for (but not limited to):
- Actively participate in project teams and collaborate with fellow team members to achieve success
- Evaluate C&Q workload and communicate any obstacles which may impact project schedules/cost/quality
- Monitor and provide timely updates on C&Q activities, including budgets and schedules
- Lead Change Requests and DR/CAPA process within the Engineering Services Department and monitor, measure and control the related process improvements
- Work with internal departments to ensure that auxiliary activities that impact C/Q/V (validation) deliverables are communicated and completed in a timely manner.
- Provide and support all C&Q activities to ensure that the C&Q component of engineering projects are executed to meet required timelines and all appropriate standards
- Prepare and execute Commissioning and Qualification protocols in line with SOPs
- Consult with Validation Manager and other Validation team members on approach and methodologies for C&Q activities
- Maintain current knowledge of qualification requirements, practices and procedures and direct C&Q team accordingly
- Influence Engineering program to ensure that design, engineering and procurement facilitate subsequent commissioning, qualification and validation.
- Perform impact assessment for changes in Facility/Utility/Equipment/Systems related to engineering projects. Review/approve change controls/CAPAs and ensure all validation related CR/CAPAs related to Engineering are closed on a timely manner
- Oversee the review and approval of all facility, utility, equipment, computer systems protocols, NCRs and reports related to Engineering projects
- Ensure all qualification activities are conducted in compliance with cGMP, company policies, safety standards and applicable SOP’s
- Take part in regulatory and/or client audit readiness and presentations
Interested candidates can send their resume and cover letter to . Please reference COMMISSIONING & QUALIFICATION (C&Q) SPECIALISTin 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.