Validation Specialist

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

**POSITION**:Validation Specialist**

**DEPARTMENT**:Technical Operations**

**SHIFT**:Days**

Reporting to the Technical Operations Manager you are responsible for supporting the Process and Cleaning validation activities including CPV program, product transfers and process developments. You will also assist in the areas of cleaning and process validation, document generation, sample and data collection.

**Responsibilities**
- Perform and co-ordinate cleaning/process validation activities including facilitating Cleaning Validation Team meetings
- Provide support required to liaise with regulatory bodies and customers during audits.
- Prepare and review validation documentation including Cleaning/Process Validation Master Plan, validation procedures, protocols, reports and methods.
- Coordinate analytical studies and cleaning procedure development and/or method development to ensure all key elements are incorporated and scientifically justified.
- Determine the cleaning validation approach as it pertains to worst-case determination by product, equipment train, hard to clean areas, residue limit calculations and analytical acceptance criteria.
- Determine the on-going maintenance of the cleaning validation program including annual monitoring, new product assessments including raw materials, revalidation activities, clean/dirty equipment hold times.
- Evaluate the effectiveness of cGMP cleaning procedures for removal of product residues, degradation products, excipients, and/or cleaning agents as well as control of potential microbial contaminants
- Collect and analyze data and prepare final reports for validation activities including CPV.
- Participate in investigations and, where required, assist with development and implementation of corrective actions.
- Ensure compliance with good manufacturing practices (cGMP) and regulatory requirements in a manufacturing environment.
- Participate in the area of occupational health, safety, and wellness.

**Qualifications**
- Bachelor’s degree in Science or Engineering, or related studies and/or equivalent combination of education and experience is required.
- Minimum 3 years of experience in a pharmaceutical manufacturing environment.
- Working knowledge in Microsoft Office and statistical data evaluation.
- Working knowledge of associated regulations that govern the pharmaceutical industry.
- Knowledge in the area of Pharmaceutical validation preferred.

**Why Bausch Health?**

Bausch Health is a dynamic, growing company with a dedicated team committed to excellence and to helping Canadians by providing them with important, high-quality healthcare solutions. It is a progressive, exciting place to work where opportunities abound for current and new employees to help make a difference for Canadians.

We strongly believe the success of Bausch Health coincides with the achievement of personal and professional goals. We are a progressive, exciting place to work - where opportunities abound for new and current employees.

Our team members work in a dynamic environment where professional and personal growth is encouraged. You have the satisfaction of knowing that you are working with dedicated individuals who share a common vision of innovation and an unrelenting focus on improving people’s lives with our health care products.

By cultivating a winning attitude, we empower employees to seize opportunities that support the company’s mission to improve people’s lives.
- What we have to offer our employees in our state-of-the-art Steinbach manufacturing site:_
- Annual Bonus Plan
- Insurance coverage (Medical - Dental - Vision - Short & Long-Term Disability - Life - AD&D)
- Employee Assistance Program (EAP)
- Employee Stock Purchase Plan (ESPP)
- Registered Retirement Savings Plan (RRSP)
- Gym on site
- Tuition Reimbursement
- INSPIRE: Employee Recognition Program
- Service Awards
- Employee Referral Program
- Top Up Maternity Leave
- Full-service Cafeteria - Free coffee & tea
- Free parking
- The masculine is used in this publication without prejudice for the sake of conciseness._
- Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates._

Bausch Health is an EEO/AA employer M/F/D/V.