Validation Specialist
About Us
Turnkey Modular Systems Inc. (TKMS) is a custom fabricator with an in-house team of professionals dedicated to the engineering, design, fabrication and delivery of Integrated Process Modular Systems.
Our services include Preliminary and Detailed Process Design, 3-D Modeling, Modular Construction, Factory Acceptance Testing (FAT), Installation, Start-Up and Commissioning.
TKMS is globally recognized for our unique expertise in the Design and Modular Construction of Custom-Designed Built to Order Process Systems and Modules specifically for the Biotech and Pharmaceutical Industries.
POSITION SUMMARY:
The Validation Inspector/Specialist is responsible for performing validation activities such as project documentation review, execution of equipment acceptance testing, and documentation turnover package assembly for custom process equipment primarily for pharmaceutical and biopharmaceutical applications.
DUTIES AND RESPONSIBILITIES:
Assist in preparing equipment acceptance test protocols based on Turnkey Modular Systems testing standards and client requirements.
Assist in the execution of factory acceptance testing on finished process systems, including the following tasks:
Process walk-downs to verify that the system is fabricated as per the engineering detailed design documents
Work with validation team to review welding documentation, vessel documentation, component certification, and engineering documentation.
Assemble physical documentation binders and electronic turnover package based on vendor documentation requirements.
Assist receiving inspectors in performing inspection and documentation activities.
QUALIFICATIONS:
Post-Secondary education in Science or Engineering preferred
Minimum 3-years experience in equipment commissioning or qualification within pharmaceutical industry.
Thorough understanding of good documentation practices.
Knowledge of biopharmaceutical/nuclear industry standards & guidelines.
Detail oriented and strong organizational skills.
Possess initiative and ability to interact with a variety disciplines and production teams.
Effective problem solving, root cause analytical skills.
Strong written and verbal communication skills.
Strong computer skills with experience using MS Office and Adobe PDF editor.
Work Remotely
Job Type: Full-time
Pay: $25.00-$35.00 per hour
Expected hours: 40 per week
Additional pay:
Benefits:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
- Wellness program
Schedule:
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Oakville, ON: reliably commute or plan to relocate before starting work (required)
Experience:
- Manufacturing: 1 year (required)
- Validation: 3 years (required)
- Document Reviewing: 3 years (preferred)
Work Location: In person
Application deadline: 2024-09-20
Expected start date: 2024-10-07
