Validation Specialist - Paris, Ontario Canada - 33646



JOB DESCRIPTION

Job #: 33646
Title: Validation Specialist
Job Location: Paris, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


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JOB DESCRIPTION

Our client in Paris, ON, is actively seeking a qualified candidate to fill the role of Validation Specialist, reporting to the Senior Manager of QA.

ESSENTIAL FUNCTIONS

  • Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). 
  • Ensure protocols provide:
  • a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes,
  • assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).
  • Responsible and accountable for the execution of Validation Protocols including:
  • observation and documentation of the equipment or process,
  • collection of samples,
  • coordination of testing and
  • coordination of third party services.
  • Perform change control assessment and determine impact to validation equipment and processes.
  • Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status.
  • Evaluate new equipment from a validation perspective through participation on the equipment selection team with engineering to ensure that new purchases will be capable of meeting validation requirements.
  • Apply statistical methods (as required) in process validations and equipment qualifications
  • Maintain Validation documentation archive ensuring prompt document retrieval when required.
  • Write Validation related SOP’s or Policies as required.
  • Collaborate with internal stakeholders to ensure equipment is qualified/re-qualified and processes are validated/re-validated as required and according to schedule.
  • Identify deviations from established process or equipment standards and provides recommendations for resolving deviations.
  • Manage effectively all assigned Validation projects.
  • Provide training specific to validation protocol requirements for sampling, to the production department
  • Train company personnel on validation related SOP’s as required.
  • Establish strong relationships inter- and intra-departmentally and provide leadership and guidance.
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer and Regulatory Audits.
  • and qualification principles, industry trends, or novel technologies.

QUALIFICATIONS

ROLE REQUIREMENTS/ABILITIES

Experience / Education

  • Degree in a relevant field, such as: Pharmaceuticals, Biotechnology, Engineering, Manufacturing, Quality Assurance, Quality Control, Laboratory Sciences Certification as a Quality Engineer, Process Analysis, Continuous Process Improvement, LEAN or Six Sigma considered an asset.
  • 3 to 5 years of experience in Validation, with experience in equipment qualification, process and cleaning validation.
  • 2 to 5 years of experience of working in Production/Quality department in pharmaceutical manufacturing environment
  • Familiarity with regulatory requirements with respect to validation and qualification activities in pharmaceutical industry.
  • Certification in Project Management, while not required is considered a plus.
  • Knowledge of GMP, Health Canada and ISO.

Skills & Abilities

  • Systems and process thinker who understands the importance of continuous improvement and how it fits within the Quality Management System and Risk Management.
  • Previous experience in process design, flow mapping, writing and conducting process validations and equipment qualifications.
  • Demonstrated ability in project management and project management tools.
  • Strong computer skills (Word, Excel, PowerPoint, Visio, etc).
  • Must be well organized.
  • Exceptional listening, communication, analytical and problem-solving skills.
  • Ability to handle multiple priorities and a dynamic changing environment.
  • Able to bring innovative solutions to process and equipment design and flow mapping.
  • Flexible, adaptable and previous experience in a fast-paced environment.
  • Strong relationship-building capabilities.
  • Collaborative, team-oriented and versatile.
  • Other duties as assigned

Physical Demands

  • May be required to stay on site for extended periods of time.

Working Environment

  • Variety of working environments including all areas of the office and plant. 
  • Occasional exposure to the smell of cannabis, chemicals and higher or lower than normal temperatures, humidity and light exposure.
  • On occasion flexible hours of work may be required to support Validation Protocol execution. 
  • Some lifting may be required, up to 25 lbs.
  • Routinely a mixture of standing/walking/sitting are required.

Education:
University - Bachelor's Degree/3-4 Year Degree

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