Validation Specialist

5 months ago

Strathroy, Canada Catalent Full time

**Validation Specialist**

**Position Summary**

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

Reporting to the Manufacturing Science & Technology (MS&T) Manager, the Validation Specialist will lead projects which include activities such as facility qualification, equipment qualification, process qualification, computer validation and cleaning/sanitation validation. The Validation Specialist will have a working knowledge of various aspects of implementing the drug development process in a regulated environment and engineering design, including topics such as Quality by Design (QbD), Design of Experiment (DOE), Good Engineering Practices, data integrity and compliance with all regulatory guidelines.

Regular working hours: 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute lunch.

**The Role**
- In collaboration with R&D, QA, Engineering and Operations plan, coordinate and drive assigned projects which include activities related to the qualification and validation of introduction, optimization, scale up or changes to facilities, equipment, computer systems, and cleaning procedures
- Work with multiple departments and Project Management, within the Catalent’s Project Management framework, to ensure timelines are met; road blocks are identified early; and resources are coordinated.
- Work with R&D, QA and Operations and participate in the evaluation and risk assessment of project data in order to: implement products and technologies into commercial production; ensure all introductions and changes are appropriately documented demonstrating proper design, qualification, operation and maintenance; assess changes to ensure validation status is maintained; and ensure introduction and changes to facilities, equipment, computer systems, and cleaning procedures meet their intended purposes
- Develop, coordinate and execute on cleaning monitoring programs as appropriate
- Establish process improvements based on trend analysis and study data; when assigned, investigate issues and customer complaints, and determine corrective actions and ensure commercial product manufacturing processes are robust
- Keep updated on regulatory guidelines
- Prepare and execute validation plans, validation/qualification protocols, validation/qualification reports and study protocols, as appropriate
- Perform other duties as required
- Bachelor’s Degree in Engineering (Chem., Indus., Mech., Elec.), Life Science, or related field
- Minimum 3+ years of experience in a validation role
- Experience working in a manufacturing, pharmaceutical and/or GMP facilities preferred
- Experience working with Computer Systems is an asset
- Knowledge of GMP compliance and regulatory requirements with a focus on validation
- Organized, good writing skills, effective attention to detail and a high degree of accuracy
- Strong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word)
- Ability to sit and use hands and fingers, to handle or feel and to manipulate keys on a keyboard
- Use of manual dexterity is required
- Ability to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl
- Vision abilities required by this job include close vision

**Why You Should Join Catalent**
- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
- Group Retirement Savings -Registered Pension Plan (RPP) with employer contributions
- Paid Time Off Programs including vacation, banked time & personal time
- Employee Reward & Recognition programs
- Opportunities for professional and personal development & growth including tuition reimbursement

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our re

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