Validation Specialist

4 weeks ago

Cambridge, Canada ATS Automation Tooling Systems Inc. Full time

**MAJOR DUTIES**:
**SPECIFIC RESPONSIBILITIES**:

- Administer, create, maintain and execute validation plans, procedures and protocols for projects.
- Work with technical and engineering personnel to prepare and create validation related documentation.
- Lead the development of equipment validation master plans.
- Organize, lead and report on validation efforts at both ATS and at the customer’s site.
- Participate in internal and customer design reviews.
- Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.
- Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
- Ensure that accurate records of all documentation delivered to customers are kept.
- Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
- Interface with manufacturing, Mechanical and Controls Engineering group.
- Have an understanding of PLCs and HMIs pertaining to validation activities.
- Contribute to the development and maintenance of internal standards.
- Ensure that all business activities are performed with the highest ethical standards and in compliance with the ATS Code of Business Conduct.
- Adhere to all aspects of the department procedures.
- Perform other duties as assigned.
- Occasional overtime and weekend work may be required.
- Adhere to customer, corporate, divisional governance requirements and associated quality procedures and policies.
- Contribute to the development and maintenance of internal standards.

**QUALIFICATIONS**:

- Bachelor’s degree or equivalent experience and greater than five years of directly related experience.
- Technical understanding of pharmaceutical / biotechnology unit operations.
- Technical understanding of general automation equipment design and principles.
- Strong communication and interpersonal skills.
- Good knowledge of cGMP requirements and current industry practices (ISPE C&Q Guidance and GAMP5).
- Demonstrate ability to work in a cross-functional team environment.
- Prior experience with automation equipment, equipment validation and project engineering would be an asset.
- Knowledge of computer programs such as Windows, Excel, Word, Outlook and Project. Should have working knowledge of AutoCAD and Solid works as well as some understanding of PLC programming software like RSLogix or Siemens Step 7.

**Additional Information**:
ALL EMPLOYEES HAVE THE RESPONSIBILITY TO WORK IN A SAFE MANNER AND REPORT ANY HEALTH, SAFETY OR ENVIRONMENTAL CONCERN TO THEIR MANAGER OR SUPERVISOR IN A TIMELY MANNER.

EMPLOYEE RESPONSIBILITIES FOR HEALTH, SAFETY AND ENVIRONMENT INCLUDE:

- Work in compliance with divisional health, safety and environmental procedures
- Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout-tagout methods
- Report any unsafe conditions or unsafe acts
- Report defect in any equipment or protective device
- Ensure that the required protective equipment is used for the assigned tasks
- Attend all required health, safety and environmental training
- Report any accidents/incidents to supervisor
- Assist in investigating accidents/incidents
- Refrain from engaging in any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct

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