Validation Specialist

Bimeda•Cambridge, ON

4d•CA$75,000 - CA$85,000•Onsite

About The Position

Reporting to the Validation Manager, the Validation Specialist initiates and executes validation studies throughout the facility. This role involves managing and facilitating the validation process from inception to completion, planning and organizing validation projects for new and existing areas, and developing standard operating procedures for validation processes. The specialist will also design and prepare protocols for various validation campaigns, coordinate validation activities, review and analyze data, and write validation final reports. Additionally, the role includes coordinating the facility qualification program and recommending validation strategies, priorities, and resources.

Requirements

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.
Strong knowledge of personal computer systems and desktop office applications.
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.

Responsibilities

Initiate and execute validation studies throughout the facility.
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.
Perform any other duties as assigned.