About Company
As a pivotal partner for innovators across North America, Career.zycto connects exceptional talent with groundbreaking opportunities. For Validation Engineers, we represent a gateway to impactful projects that demand precision, analytical rigor, and a commitment to quality. Our extensive network features leading organizations that are shaping the future of various industries, providing an ideal platform for professionals seeking to advance their careers in a challenging yet rewarding environment. Join us and discover where your expertise can make the biggest difference, ensuring products meet the highest standards of safety and efficacy.
Job Description
We are seeking a highly skilled and meticulous Validation Engineer to join one of our innovative client teams, located in the vibrant Willowdale area of Toronto. This full-time, on-site role is critical for ensuring that all systems, equipment, and processes meet stringent regulatory requirements and quality standards. As a Validation Engineer, you will play a pivotal role in the lifecycle of critical manufacturing and operational systems, from initial design specifications through to successful implementation and ongoing maintenance. Your expertise will directly contribute to the integrity and reliability of our client’s products, impacting patient safety and market success in regulated industries.
This position demands a professional with a strong understanding of validation principles, GxP guidelines (GMP, GLP, GCP), and a proactive approach to problem-solving. You will be responsible for developing, executing, and documenting validation protocols for a wide range of equipment, processes, and computer systems. This includes Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The successful candidate will work collaboratively with cross-functional teams including R&D, Quality Assurance, Manufacturing, and IT to ensure seamless integration of validated systems.
We are looking for someone who thrives in a dynamic environment, possesses excellent analytical abilities, and can communicate complex technical information clearly and concisely. If you are passionate about quality, regulatory compliance, and contributing to the development of world-class products, we encourage you to apply. This is an exceptional opportunity to advance your career within a forward-thinking organization that values precision, innovation, and continuous improvement.
Key Responsibilities
- Develop, review, and execute comprehensive validation protocols (IQ, OQ, PQ) for manufacturing equipment, utilities, facilities, and computer systems.
- Perform risk assessments and define acceptance criteria for validation activities.
- Analyze validation data, prepare detailed reports, and present findings to relevant stakeholders.
- Ensure all validation activities comply with industry standards, regulatory requirements (e.g., Health Canada, FDA, ISO), and internal quality procedures.
- Collaborate with Engineering, Manufacturing, Quality Assurance, and IT departments to integrate validation requirements into project lifecycles.
- Investigate and troubleshoot validation deviations, implementing corrective and preventive actions (CAPAs).
- Maintain the validated state of systems through revalidation, periodic reviews, and change control processes.
- Provide technical guidance and training on validation principles and practices to junior staff and cross-functional teams.
- Participate in internal and external audits, providing expert support and documentation.
- Stay updated with industry best practices, emerging technologies, and evolving regulatory landscapes in validation.
Required Skills
- Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field)
- 4+ years of experience in validation within a regulated industry (e.g., pharmaceutical, biotechnology, medical device, food & beverage)
- Strong understanding of GxP regulations (GMP, GLP, GCP) and industry standards (e.g., ISO 13485, 21 CFR Part 11)
- Proven experience in developing and executing IQ, OQ, PQ protocols
- Proficiency in statistical analysis and data interpretation related to validation
- Excellent technical writing and documentation skills
- Strong problem-solving and analytical abilities
- Ability to work independently and collaboratively in a team environment
Preferred Qualifications
- Master's degree in a relevant engineering discipline
- Certification in Quality Assurance or Validation (e.g., ASQ Certified Quality Engineer)
- Experience with Computer System Validation (CSV)
- Familiarity with Lean Manufacturing or Six Sigma methodologies
- Project management experience in a regulated environment
Perks & Benefits
- Competitive salary and performance bonuses
- Comprehensive health and dental benefits package
- Generous paid time off and holidays
- Retirement savings plan with company match
- Opportunities for professional development and continuous learning
- Collaborative and innovative work environment
- On-site fitness facilities and wellness programs
- Employee assistance program
How to Apply
Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience. Please click on the application link below to apply for this exciting opportunity. We thank all applicants for their interest, however, only those selected for an interview will be contacted.
