About Company
Hiring.zycto is rapidly expanding its footprint in the advanced biopharmaceutical manufacturing sector, driving innovation and precision in every process. We understand that a Senior Validation Engineer like you thrives on meticulous detail, rigorous compliance, and the profound impact of ensuring product quality and patient safety. Here, your expertise will be pivotal in shaping our operational excellence, translating into tangible advancements for healthcare globally. Join a culture that values scientific integrity, collaborative problem-solving, and continuous professional growth. We are building the future of pharmaceuticals, and your contribution is essential to our mission.
Job Description
Are you a highly experienced and meticulous Validation Engineer ready to take on a leadership role within a dynamic pharmaceutical environment? Hiring.zycto is seeking a Senior Validation Engineer to join our cutting-edge facility in Calgary. This pivotal role involves overseeing and executing comprehensive validation strategies for critical systems, equipment, processes, and facilities in compliance with stringent regulatory standards (e.g., Health Canada, FDA, EMA). You will be instrumental in ensuring the highest levels of quality, safety, and efficacy for our pharmaceutical products, directly contributing to patient well-being.
As a Senior Validation Engineer, you will lead complex validation projects from inception to completion, applying your profound knowledge of cGMP, GAMP 5, and ICH guidelines. Your responsibilities will span across various validation lifecycle phases, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and revalidation activities. You will mentor junior engineers, drive continuous improvement initiatives, and collaborate cross-functionally with R&D, Quality Assurance, Manufacturing, and Engineering teams. This is an an exciting opportunity for a seasoned professional to make a significant impact, drive best practices, and contribute to the growth of a forward-thinking pharmaceutical company dedicated to innovation and excellence. We are looking for someone who can navigate complex technical challenges, champion compliance, and foster a culture of quality.
Key Responsibilities
- Develop, execute, and review comprehensive validation protocols (IQ, OQ, PQ, CSV) for equipment, processes, utilities, and computer systems in accordance with cGMP, Health Canada, FDA, and EMA regulations.
- Lead and manage complex validation projects from planning through execution and reporting, ensuring timely completion and adherence to project scope, budget, and quality standards.
- Perform detailed risk assessments, gap analyses, and root cause investigations related to validation deviations, implementing effective corrective and preventive actions (CAPA).
- Prepare robust validation reports, summaries, and associated documentation for regulatory submissions, internal audits, and external inspections.
- Provide expert guidance and mentorship to junior validation personnel and cross-functional teams on validation principles, methodologies, and regulatory requirements.
- Collaborate closely with Quality Assurance to ensure all validation activities align with the Quality Management System and maintain continuous inspection readiness.
- Stay abreast of industry best practices, technological advancements, and evolving regulatory requirements in pharmaceutical validation to continuously improve our validation strategies and processes.
Required Skills
- Minimum of 6 years of progressive experience in validation within the pharmaceutical or biotechnology industry.
- Demonstrated expertise in GxP regulations (cGMP, GLP, GCP), particularly Health Canada, FDA 21 CFR Parts 210, 211, and ICH guidelines.
- Proven experience with Computer System Validation (CSV), GAMP 5, and data integrity principles.
- Strong background in all phases of the validation lifecycle documentation (URS, FRS, DQ, IQ, OQ, PQ).
- Proficiency in risk assessment methodologies (e.g., FMEA) and statistical process control.
- Excellent analytical, problem-solving, and decision-making skills with a keen eye for detail.
- Exceptional written and verbal communication skills for technical report writing, presentations, and cross-functional collaboration.
- Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Electrical) or a related scientific field from an accredited institution.
Preferred Qualifications
- Master's degree in a relevant engineering or scientific discipline.
- Professional Engineer (P.Eng) designation or equivalent certification.
- Experience with lean manufacturing principles and Six Sigma methodologies in a pharmaceutical setting.
- Familiarity with environmental monitoring, aseptic processing, and sterile manufacturing processes.
- Project management certification (e.g., PMP).
Perks & Benefits
- Competitive salary and performance-based bonuses tied to company success.
- Comprehensive health, dental, and vision insurance plans with extensive coverage.
- Generous paid time off and holidays, promoting work-life balance.
- Defined contribution pension plan with robust company matching program.
- Opportunities for professional development, ongoing training, and continuous learning to advance your career.
- Employee wellness programs and access to on-site or subsidized fitness facilities.
- Modern, state-of-the-art office and laboratory environment designed for collaboration and innovation.
- Relocation assistance for eligible candidates moving to Calgary.
How to Apply
Ready to advance your career and make a real impact in the pharmaceutical industry? Click on the application link below to submit your resume and a compelling cover letter. Please highlight your relevant experience in pharmaceutical validation, your leadership capabilities, and your approach to ensuring stringent regulatory compliance. We look forward to reviewing your application!
