Validation

Job Titles

  • Validation Associate
  • Validation Specialist
  • Validation Tech

Educational Background

  • B.Sc.
  • B.Eng.

Job Functions

  • There are 4 core responsibility
    1. Equipment Validation
    2. Facility Validation
    3. Process Validation
    4. Cleaning Validation
    5. Troubleshooting as needed

Equipment validation

  • Perform Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) on new manufacturing equipment
    • Start by drafting a protocol for each qualification, execute the protocol, draft Standard Operating Procedures (SOP), ensure the results meet the specification and release the equipment.
  • Ensure the equipment purchased are made of approved grade of stainless steel
  • Draft validation report with results summarized, conclusion and recommendation
  • Re-evaluate the equipment if it’s been repaired and moved

Facility validation

  • HVAC Qualification
    • Check the air floor, temperature and humidity
  • Qualification of Facility itself (GMP rooms/ areas only)
    • Verify to ensure the facility is cleanable. Example, the floor/ ceiling is made of material that are easily cleanable.
  • Compressed Air Qualification
    • Verify the oil particulates, microbial and moisture is within specification
  • Water System Qualification
    • Depending on what it’s used for, qualify it by ensuring it meets the USP requirements
  • Draft Validation report with results summarized, conclusion and recommendation.
  • Perform annual monitoring

Process Validation

  • Verifying the process is repeatable and is capable of consistently producing products that meets the predetermined specification
  • Manufacture multiple batches  consecutively following the process and perform extensive testing before considering the process is validated and ready to b e used for manufacturing the product for commercial distribution.
  • Follow as per Health Canada Validation guideline  GUI-0029
  • Draft validation report with results summarized, conclusion and recommendation

Cleaning validation

  • Designed to verify there is  no cross contamination when product B is manufactured using the same equipment as product A. This is done by validating the equipment cleaning procedure .
  • As part of cleaning validation, perform
    • Dirty Hold Time and Campaigning studies and test the sample for microbial growths, detergent residue and API residue.
    • Environmental Monitoring: take samples of the air in the GMP manufacturing areas, equipment and the room itself (door, table, wall) to ensure the room has been cleaned properly and the air is clean. Test the samples for microbial.

Troubleshooting

An example of a troubleshooting:

If there is a change in the previously validated process, validation associate will have to determine whether the process needs to be validated. If so, full validation or partial validation.

Must Have Skills

  • Excellent Communication skills (written and verbal) & interpersonal skills
  • 1-3 years of validation associate experience will benefit
  • Good troubleshooting skills
  • Attention to details
  • Ability to follow written procedure with no deviation
  • Attention to details
  • Willing to learn

Type of companies that hire

  • Pharmaceutical
  • Biopharmaceutical
  • Regulatory Agencies (Health Canada)
  • Biotech
  • Contract Labs
  • Cannabis Industry
  • Food Industry
  • Cosmetic companies
  • other

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