Specialist II, Validation

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

The Validation Engineer II / Specialist II supports validation activities across clinical and commercial manufacturing, contributing to the regulatory compliance and quality of products manufactured at the site. As a skilled specialist, the incumbent identifies and executes validation work based on business need, manages small projects end-to-end, coordinates with external consultants, and prioritizes multiple concurrent activities with limited supervision.

Ontario Note: In Ontario, this role may be titled Specialist II, Validation where the incumbent does not hold a recognized engineering degree or professional engineering designation. The job profile, responsibilities, level, and compensation range are identical; only the business title differs to reflect the applicable credential pathway.

Job Responsibilities

Commissioning, Qualification & Validation

• Perform impact assessments for changes affecting validated equipment, utilities, facility systems, processes, and cleaning systems.

• Support FAT, Commissioning, and SAT activities for new equipment and new/renovated facilities.

• Prepare and execute Validation Protocols (IQ/OQ/PQ/PV/CV) for new and existing equipment, utilities, facility systems, computerized systems, processes, and cleaning, in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry best practices.

• Compile and analyze validation data against protocol acceptance criteria, and prepare validation summary reports.

• Troubleshoot equipment and process issues encountered during qualification and validation activities, and determine and implement corrective solutions.

Compliance & Continuous Improvement

• Ensure all validation activities are conducted in compliance with cGMP, applicable regulations (including 21 CFR Part 11 and EU GMP Annex 1, Annex 11, and Annex 15), company policies, safety standards, and SOPs.

• Contribute to and maintain assigned sections of the Validation Master Plan to ensure ongoing compliance.

• Identify and initiate improvements to validation procedures and templates within the area of responsibility.

• Identify and report deviations affecting product quality or validation status; investigate root cause; and initiate, action, and close the associated deviations, change requests, and CAPAs through to closure.

Project Management & Cross-Functional Coordination

• Coordinate with design, construction, and internal teams to support capital and client projects.

• Track project scope, schedule, and budget for assigned engineering projects; escalate risks and issues to the Engineering Manager in a timely manner.

• Prepare and present project status updates to the Engineering Manager and cross-functional stakeholders.

• Coordinate with cross-functional teams including Quality, Maintenance, and Operations to support site-wide validation activities.

Experience & Education

Minimum Qualifications

• Working knowledge of cGMPs, biopharmaceutical industry guidelines, and applicable regulatory frameworks (FDA, Health Canada).

• Demonstrated ability to execute validation protocols (IQ/OQ/PQ) and corresponding summary reports.

• Working knowledge of 21 CFR Part 11, EU GMP Annex 1, 11 and 15, and computer system validation (CSV) requirements.

• Working knowledge of quality system processes including deviations, CAPAs, and change control, with experience driving records through to closure.

• Strong organizational, presentation, and technical writing skills.

• Ability to compile, analyze, and interpret validation data against protocol acceptance criteria, including basic statistical techniques.

• Ability to work independently with minimal guidance and collaborate effectively within a high-functioning team.

Preferred Qualifications

• Bachelor's degree in engineering or science; Master's degree preferred.

• 2+ years of direct validation experience, or Process/Product Engineering Compliance experience, in a biopharmaceutical environment.

• Experience or working knowledge in any of the following: aseptic manufacturing, aseptic process simulation, sterilization, temperature mapping, process validation, computerized system validation, and cleaning validation

• Ability to perform risk and impact assessments for changes affecting validated equipment, utilities, systems, or processes

• Proficiency with electronic quality management systems (e.g., TrackWise, Veeva, MasterControl) and standard productivity tools (Microsoft Word, Excel, Visio).

Physical & Work Environment

Physical demands may include standing for extended periods, crouching/squatting, ability to lift up to 10kg (22lbs).

Work Schedule

[examples: 8 hours - Monday- Friday; 10 hours – Monday-Thursday; 12 hour – 2/2/3]
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.

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.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $70,000.00 - $96,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.