Validation Specialist

**Validation Specialist - Contract**

Windsor, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

**Position Summary**

Reporting to the Director, Technical Services, the Validation Specialist will lead projects which include activities such as facility qualification, equipment qualification, computer validation, and cleaning 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.

**The Role**
- In collaboration with R & D, QA and Operations plan, coordinate and drive assigned projects which include activities related to the evaluation of raw materials and execution of risk assessments for cleaning of new products to ensure timelines are met; roadblocks 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
- Represent department on technical basis for assigned projects.
- Effectively communicate on a timely basis with management and other departments within Catalent and customers to ensure clear understanding and acknowledgement of project status, risks, actions, and outcomes.
- Prepare and execute validation plans, validation/qualification protocols, validation/qualification reports and study protocols, as appropriate.
- Participate in risk assessments to develop validation/qualification approaches.
- Operate under and maintain GMP conditions.
- Represent projects at local and technical meetings.
- Minimum of a bachelor’s degree in Engineering (Chem., Indus., Mech., Elec.), life science (Chemistry, Biochemistry, Biology) or related field.
- Experience working in validation within a pharmaceutical manufacturing environment preferred.
- Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
- Must be organized and possess good writing skills.
- Good computer skills (Word, Excel).
- Knowledge of pharmaceutical manufacturing processes.
- Organized, good writing skills, meticulous.

**Working Conditions**
- Regular working hours: 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch
- 18-month contract
- The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard.
- Use of manual dexterity is required.
- The employee is occasionally required 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.
- There is also the potential exposure to chemicals.

**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 recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.