RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.
We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.
We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.
The position is 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.
- 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 SOPs
- 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
- Performs all other related duties as assigned
TECHNICAL KNOWLEDGE / EXPERIENCE:
- University degree in Engineering or Science
- Knowledge and understanding of chemistry, engineering, pharmaceutical processes and concepts
- Knowledge and understanding of cGMPs and biopharmaceutical industry guidelines
- Knowledge and understand of 21 CFR Part 11 and associated computer validation standards
- Must have good organizational, presentation and technical writing skills
- Must be confident to work independently with minimal guidance
- Must be able to work well as part of a high functioning team
PREFERRED QUALIFICATIONS / EXPERIENCE:
- 1 or more years of direct validation experience or Process/Product Engineering Compliance related experience in biopharmaceutical environment, experience with 21 CFR Part 11 and cGMP regulations
- Experience in one or more of the following areas is desired: aseptic filling equipment, autoclaves, temperature mapping
- Experience in process validation, cleaning validation, sterilization
- Aseptic manufacturing knowledge
- Pre-employment medical, and medical re-examination performed every 2 years or as per Resilience’s SOPs
- This position requires vaccination for Hepatitis A and B
- Job requires occasional shift work, weekends, extended shifts, and possible short notice schedule shifts
While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), 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 directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), 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).
Resilience Biotechnologies Inc. (RESILIENCE), 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