Validation Specialist

bimeda; Cambridge; On-site; CAD 75,000 - 85,000; Full time

Benefits offered by this job

13 paid holidays

Vacation policy

5 paid personal care days

Employee Assistance Program

Medical, dental, vision, STD & LTD

Job summary

Bimeda in Cambridge, Ontario is seeking a Validation Specialist to initiate and execute validation studies across the facility.

Reporting to the Validation Manager, you will plan IQ/OQ/PQ campaigns, write protocols, coordinate with QC/QA, Production and Maintenance, and develop SOPs for plant processes.

Requires GMP documentation experience in pharma, a BSc/Engineering degree, strong communication, and willingness to work after hours; salary CAD 75,000–85,000 DOE.

Qualifications

• Must have at least 1 year updating GMP relevant documentation in a Pharmaceutical environment.
• Bachelor’s degree in science or Engineering is required.
• Strong interpersonal, written and verbal communication, organizational and planning skills.
• Willingness to work off hours when needed to support production.

Responsibilities

• Interact with all levels of management to manage and facilitate validation projects from inception to completion.
• Plan, schedule and organize validation projects for manufacturing processes and equipment; prepare project plans.
• Develop and implement SOPs for validation of plant processes, IQ/OQ/PQ and requalification.
• Design IQ/OQ/PQ campaigns and prepare validation protocols and final reports.
• Coordinate validation activities with production, QC/QA, and outside contractors; provide leadership and training.

Skills

GMP Documentation

Validation Studies

Project Management

Cross-functional Teamwork

Communication

Attention to Detail

Education

Bachelor’s degree in science or Engineering

Job description

Job Title: Validation Specialist
Location: Cambridge, ON (In-Office)
Position Type: Full-time regular

Shift: Day Shift, Monday - Friday
Vacancy Status: This role is currently vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

Reporting to the Validation Manager, the Validation Specialist initiates and executes validation studies throughout the facility.

Key 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

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

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
• 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.

Compensation & Benefits

• Competitive salary.
• 13 paid holidays.
• Competitive vacation policy effective upon hire.
• 5 paid personal care days.
• Employee Assistance Program.
• Medical, dental, vision, STD & LTD benefits.
  Expected Salary Range: $75,000 - $85,000K / Year, DOE

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 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.
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