Process Validation Manager

2 weeks ago

Cambridge, Canada Bimeda Full time

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 which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

**Role Summary**

The Process Validation Manager reports to the Director of Technical Operations and is responsible for the execution and regulatory compliance of the validation program. The Process Validation Manager is well-versed in the generation, execution, modification, and summation of Validation documents to ensure Good Documentation Practices within pharmaceutical operations. This role serves to ensure products and processes are maintained in a validated state and compliant with regulatory and cGMP requirements throughout the product lifecycle. This is accomplished through interaction and coordination of activities with all relevant departments within the organization.

**Role Requirements**
- Collaborates with all levels of the organization to lead the development and implementation of standardized validation protocols, validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification of critical systems, utilities and production processes.
- Designs IQ/OQ/PQ and validation campaigns, develop, prepare and write protocols for process validation, cleaning validation, IQ/OQ and performance qualification.
- Provides technical leadership on validation best practices, ensuring alignment with regulatory requirements and industry standards. Areas of expertise include commissioning, qualification, sterilization, aseptic processing, Cleaning Validation, Process Validation, and Computer System Validation.
- Independently leads validation projects across process, packaging, plant systems or cleaning validation
- Leads technical investigations, process improvements and site validation programs
- Establish and maintain strong relationships with internal and external customers to achieve desired outcome of a robust and compliant validation program that ensures its on-time completion to the schedule and committed action.
- Provide leadership and guidance on new and/or existing validation topics.
- Leads the hiring process and manages the performance and development of direct reports, including conducting employee performance reviews, implementing improvement initiatives and resolving conflict.
- Leads, directs, evaluates and develops the team in alignment with Bimeda’s Mission, Vision, and Values, policies and standard operating procedures.
- Acts as an ambassador for modeling and promoting a safe work environment, enforcing safety rules and regulations.
- Conduct training to support new hires and junior team members.
- Support product and facility investigations as required from a validation perspective in order to assess impact and make recommendations to remediate and/or mitigate against risks to the process and facilities.
- Work with Regulatory Affairs Department to provide validation support for regulatory submissions.
- Prepare validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation and other additional studies.
- 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.
- Flexible to work extended hours or off-shifts based on project expectations (as required).
- Any other duties as assigned.

**Competencies Required for the Role**:

- **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.
- **ANALYTICAL THINKING/PROBL

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