Validation Specialist

2 weeks ago

Cambridge, Canada Bimeda Full time

**Purpose of the Position/Role Summary**
Reporting to the Validation Manager, the Validation Specialist initiates and executes validation studies throughout the facility.

**Role Specific Requirements**:

- Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects
- Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment. Prepare project plans. Identify necessary internal and external resources for completion of validation projects and secure the necessary support (Production, Maintenance, QC, QA, outside contractors). Interface extensively with the QC/QA, Production and Maintenance departments to identify projects and problems requiring validation support. Plan and assign priorities to ensure critical projects meet required deadlines. Work with Regulatory Affairs Dept. to provide validation support for regulatory submissions
- Develop and implement all necessary standard operating procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification of critical systems, utilities and production processes
- Design IQ/OQ/PQ and validation campaigns, develop, prepare and write the protocols for process validation, cleaning validation, IQ/OQ and performance qualification
- Coordinate validation and IQ/OQ/PQ activities with production, quality control laboratories and outside contractors providing leadership, training and guidance. Monitor and support the execution of the protocols through training, facilitating, and problem-solving activities. Assure appropriate testing, and support methods validations are completed through extensive interaction with quality control and R&D
- Review and analyze moderately complex analytical and physical data generated from validation activities. Write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis
- Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results, and assisting production in resolving any identified problems
- Recommend validation strategies, priorities, and resources. Accountable for accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities, accountable for meeting critical deadlines for complex projects
- Any other duties as assigned

**Competencies Requires for the Role**:
**PROCESS IMPROVEMENT** - involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.

**PLANNING **- is the process of thinking about and organizing the activities required to achieve a desired goal.

**FOSTERING COLLABORATION/TEAMWORK**:

- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

**EFFECTIVE COMMUNICATION**:

- **Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

**RESULTS ORIENTATION **- The ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on the goals, and meeting or exceeding them.

**Other Requirements**
- Must have a minimum of 1 year of experience updating GMP relevant documentation in a Pharmaceutical environment
- Bachelor’s degree in science or Engineering
- Strong interpersonal, written, oral, communication, organizational and planning skills
- Sound understanding of scientific principles communication and project management skills
- Willingness to work off hours e.g. after hours, weekends etc. whenever access that is not disruptive to production is required or given.

**About Bimeda**

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline wh

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