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Tuesday, 17 May 2022 20:00

Validation Specialist

  Cambridge, ON,  Canada |  Full time

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Posting Date :  2022-04-26

Job Identification :  10986

Department  :  Validation

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Role Summary: Reporting to the Validation Manager, the Validation Specialist is responsible for initiating and executing validation studies throughout the facility supporting re-validation initiatives, departmental and capital projects.

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 to 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 and implement validation strategies considering 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.

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/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach.  Ability to identify and separate the key components of problems and situations.  Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
  • THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
  • INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
  • CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change.  The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change.  Strives for continuous improvement.

What You Bring to The Role:

  • Bachelors degree in Science or Engineering
  • 1–3 years experience in a similar role 
  • Strong interpersonal, written, oral, communication, organizational and planning skills
  • Strong knowledge of personal computer systems and desktop office applications
  • Willingness to work off hours e.g. after hours, weekends etc. whenever access that is not disruptive to production is required or given.
  • Previous pharmaceutical experience in a similar role (Validation or Engineering) as asset.
  • Sterile pharmaceutical experience as asset.
  • One (1) year experience updating GMP relevant documentation in a Pharmaceutical environment an asset.
  • Sound understanding of scientific principles communication and project management skills

 

What We Offer:

  • Competitive Salary
  • Paid Holidays
  • Competitive Vacation Policy
  • Paid Sick Days
  • Medical, Dental, Vision Insurance
  • Defined Contribution Pension plan - matching at 5%
  • Employee Assistance Program

At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.

The job posting is available in an accessible format upon request by contacting the Human Resources Manager.

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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More Info at www.bimedacareers.com

 

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