Validation Specialist I Technical Operations Validation
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, from 2014 to 2017, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
The Validation Specialist will be accountable to support all Validation 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 support to the validation program which directly impacts the regulatory compliance status of the company. The validation specialist will be able to manage small projects, consultants and prioritize numerous projects.
Here is what we are looking for:
- University degree in Engineering or Science
- 1+ year of direct validation experience or Process/Product Engineering Compliance related experience in biopharmaceutical environment is ideal
- Experience in the following areas is desired: aseptic filling equipment, autoclaves, temperature mapping, and process validation.
- Experience in cleaning validation is a bonus.
- Preferred knowledge and understanding of equipment, CIP and SIP systems
- Preferred knowledge and understanding of cGMPs and biopharmaceutical industry guidelines
- Must have good organizational, presentation and technical writing skills
- Must be confident to work independently with minimal guidance
Here is what you will be responsible for (but not limited to):
- Perform Impact Analysis for changes in Equipment, Utilities, Facility Systems, Process and Cleaning Systems and parameters
- Support FAT, Commissioning/SAT activities of new equipment, and new/renovated facilities
- Lead and or support IQ/OQ/PQ activities of new or existing equipment, and new/renovated facilities
- Prepare and Execute Validation Protocols (IQ/OQ/PQ/PV/CV) for: Equipment, Utilities, Facility Systems, Process, and Cleaning in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry best practices
- Compile required data and perform data analysis as required per validation protocols
- Investigate and troubleshoot problems and determine solutions
- Prepare validation reports
- Ensure all Validation activities are conducted in compliance with cGMP, company policies, safety standards and applicable SOP’s
- Assist in maintaining and updating the Validation Master Plan as required, to remain compliant
- Initiate changes to assure continuous improvement of procedures
- Report and record any deviations from company procedures or other discrepancies that may affect or indicate a problem with product quality. Determine and implement any immediate corrective action as necessary and ensure the development and implementation of long term corrective actions by identifying root cause and facilitating the final implementation of the corrective actions
- Coordinate with other departments and consultants for validation activities
- Support initiation, actions and closure of Change Requests and CAPAs, as required
Interested candidates can send their resume and cover letter to email@example.com. Please reference Validation 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.