Validation Specialist

2 months ago

Oakville, Canada TKMS Full time

_**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.

***:
**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
- No

Pay: $25.00-$35.00 per hour

Expected hours: 40 per week

Additional pay:

- Overtime 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

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