Senior Instrumentation and Equipment Specialist

2 weeks ago

Markham, Ontario, Canada Shields Pharma Inc. Full time
Job Summary

Shields Pharma Inc. is a leading pharmaceutical organization committed to excellence in quality and innovation. We are seeking a highly skilled and experienced Senior Instrumentation and Equipment Specialist to join our team.

Key Responsibilities
  • Perform qualification, calibration, and preventative maintenance of laboratory and facility instrumentation and equipment in accordance with Shields Pharma Inc.'s SOPs and policies, GXP, ICH, GAMP, FDA CFR 211, and other regulatory guidelines.
  • Conduct troubleshooting and repairs of laboratory and facility equipment and instrumentation, and control systems.
  • Develop and implement technical SOPs and calibration procedures based on field experience.
  • Support and oversee contractors and service providers performing tasks within the company, ensuring adherence to company safety requirements and cGMP standards.
  • Prepare accurate and comprehensive qualification and calibration protocols and reports in accordance with company policies, procedures, GDP, and cGMP.
  • Complete calibration, PM, and repair documentation accurately and comprehensively, including work orders and logbooks, in accordance with Shields Pharma policies and procedures, ALCOLA+, FDA CFR 211, and others.
  • Participate in Quality Assurance investigations of instrument failures/breakdowns.
Requirements
  • Permanent Canadian residency with work permit and/or Canadian citizenship.
  • Minimum Science degree in Chemistry, Analytical Chemistry, Mechanical/electronic Engineering, or similar applied scientific disciplines.
  • Minimum of 3-4 years of direct and hands-on experience working in equipment and instrumentation, qualification, calibration, PM, trouble shooting, and repairs in pharmaceutical laboratory and production environment.
  • Demonstrate solid technical knowledge and extensive expertise on operation, qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment, including LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, ICP-MS, and dissolution.
  • Basic understanding of pneumatic, electrical, and mechanical control systems, such as PID Controllers, smart devices, programmers/communicators, and multimeters.
  • Proficient in Microsoft Office Applications, including Microsoft Word and Excel.
Preferred Qualifications
  • Demonstrate strong people and interpersonal skills, including being a team player, problem solver, active listener, and easy to work with.
  • Clear, concise, and effective communication and written skills when describing technical matters or issues.
  • Detail-oriented, focused on each project, and able to complete tasks efficiently.
Work Environment

This is a full-time position, Monday to Friday, with a Bachelor's Degree preferred.

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