Validation Specialist

Jobinhalt

About Capcium

We are an innovative, fully licensed value-add service platform provider for customers in the Pharmaceutical, Over the Counter and Health & Wellness industries. Capcium has developed a best-in-class team of softgel encapsulation professionals leveraging decades of manufacturing expertise, customer support experience and formulation customization knowledge from leading softgel manufacturers. We are dedicated to delivering the best customer experience and providing quality products while keeping our core values at the heart of everything we do.

Why work at Capcium

We are a continuously growing company offering a unique opportunity to learn and be apart of a dynamic team. While ensuring high-quality service throughout every point in the journey, we strive for open and honest communication to create strong relationships between employees and customers. We foster a collaborative environment to ensure a drive towards shared goals and success. Our foundation is based on integrity and agility, ensuring trust amongst coworkers and quick responses to rapid changes in the internal and external environments.

Overview

The Validation Specialist is responsible for carrying out validation/qualification activities for production and laboratory equipment (i.e. steam sterilizer, incubator), systems, utilities, processes, and cleaning at Capcium. The incumbent will need to ensure that all stages of the project are conducted in accordance with standard procedures (Health and Safety, Good Manufacturing Practices, 21 CFR part 11 requirements, etc.). He/she will coordinate the activities of all parties involved: professionals, contractors, consultants, and serve as a link to internal customers. He/she will also review and approve documents (protocols and reports). The mandate also includes validation change management.

Main Responsibilities

• Validation Strategies
• Participate in the development of validation / qualification strategies
• Participate in the drafting / revision of the Validation Master Plan (VMP);
• Validation Protocols & Activities
• Draft and execute qualification protocols and reports (IQ, OQ and PQ when relevant) as well as process and cleaning;
• Assist and coordinate external suppliers on site for validation activities;
• Support the engineering team during the selection of new equipment, equipment start-up (FAT and / or SAT);
• Plan and execute qualification/validation protocols within the expected timelines;
• Analyze and perform assessments using a risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security. Following the assessment, assign appropriate levels of validation;
• Deviations & Investigations
• Write deviations that occur during validation/qualification and recommend corrective actions;
• Participate in the resolution of gaps, investigations, and deficiencies
• Documentation
• Prepare and approve validation documentation packages, including development and execution of documentation for validation and qualification activities to support various validation projects
• Documents may include: Validation master plan, validation protocols and reports, User Requirements Specifications, Requirements Trace Matrix, Functional and Design Specifications, Protocols (IQ/OQ/PQ), User Acceptance Testing, SOP’s, Change Control Documentation, and Risk Assessment reports;
• Write SOPs and validation protocols in accordance with corporate standards and current GMPs;
• Maintain validation / qualification documentation and archiving by ensuring efficient document retrieval, when requested;
• Back-up for this role is the validation manager.

Qualifications

• Bachelor’s degree in Engineering (Chemistry or Mechanics) or Science: Chemistry, Biology, Biochemistry
• Minimum of 3 years of experience in validation in the pharmaceutical industry
• Experience in qualification of equipment used in manufacturing and / or packaging of various dosage forms as well as critical systems (HVAC, purified water, compressed air)
• Experience in validation of cleaning methods and manufacturing processes.
• Knowledge of use of Kaye Validator
• Excellent working knowledge of cGMP requirements on validation methods and including ISPE, GAMP and FDA principles, CFR Part 11 (requirements for electronic records and signatures)
• Capable of developing and writing applicable validation documentation, including but not limited to URS, DOE, FAT, IQ, OQ
• Experience in project management would be an asset
• Bilingual: French and English, spoken and written
• Capable of managing multiple complex projects and working independently
• Ability to review and approve technical reports effectively
• Ability to write technical reports clearly and accurately
• Can work under pressure and adaptation to changes
• Good sense of communications and emergencies (prioritization)
• Multifunctional teamwork
• Proficient in computer tools like Microsoft Office, Outlook, MS Project
• Office and factory work
• Travel to production sites may be required