ABOUT SHIELDS PHARMA INC.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.
We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance.
Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do. You can count on;

• Safety as it is our first core value,
• Integrity
• Accountability, and
• Continuous Training and skill development

We are currently looking for the following individuals to join our growing team!
Position Title: Senior Pharmaceutical Laboratory Systems and Maintenance Metrologist (Full-time)
Reports To: Head of Operation

JOB DESCRIPTION:

Senior Metrologist plays a crucial role in ensuring measurement accuracy and quality control across pharmaceutical laboratory and production settings.
Senior Metrologist is responsible for calibrating precision instruments and conducting advanced measurements. He/she must develop and implement calibration procedures for a wide range of instruments and equipment used in laboratory operations from simple tools to sophisticated electronic devices.
This is a highly technical position involving qualification, calibration, preventative maintenance, and repairs of the of laboratory and facility equipment and instrumentation in accordance to Shields Pharma Inc. operation and calibration SOPs and policies and applicable regulatory guidelines and standards, such as GMP, GXP, ISO 17025, ICH, GAMP, FDA CFR 211, ALCOLA+, etc.

Should demonstrate multi-tasking abilities working in a fast pace changing environment

• Must demonstrate clear, concise, and effective communication and written skills when describing technical matters or issues.
• Must be detail-oriented being focused on each project and be able to complete tasks efficiently.
• Should be able to clearly and neatly describe technical issues and be able to document work performed accurately in a technical manner

• Preparation of instrument and equipment qualification (IQ, OQ, PQ), and calibration protocols and reports.
• Performing Shields Pharma instrument and equipment IQ, OQ, PQ qualification and Calibration activities.
• Precise calibration of analytical instruments and equipment in a controlled laboratory setting
• Developing and implementing quality control calibration, preventative maintenance, and operation and procedures.
• Performing scheduled maintenance on active instrumentation and equipment.
• Performing preventive maintenance (PM), troubleshooting, and repairing laboratory and facility equipment and instruments.
• Executing Repairs and accurately documenting repair activities.
• Assessing instrument failures/breakdowns, systematically identifying problems, and restoring to operation
• Reviewing and updating calibration procedures based on field experience.
• Preparing SOPs pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment
• Supporting, overseeing, and supervising contractors/services providers performing tasks within the company and ensuring the external contractor/s are adhering to the company safety requirements and cGMP standards.
• Analyze measurement data to identify trends and potential issues in production processes.
• Identifying opportunities for improving Shields Pharma’s metrology programs.
• Maintaining procedures and work instructions for asset management, calibration, and maintenance.
• Performing Risk Assessment on the company instrumentation and equipment.
• Preparing accurate and comprehensive qualification and calibration protocols and reports in accordance to the company policies, procedures, GDP, and cGMP.
• Calibration and maintenance of sophisticated laboratory equipment and instrumentation such as HPLC, LC-MS, GC, GC- Headspace, GC/MS, ICP-MS, Dissolution, etc. in compliance with the company policies and SOPs, and regulatory requirements.
• Participate in to testing anomaly (OOT) and or failure investigations, using your expertise to identify potential instrument and measurement-related issues
• Completing calibration, PM, and repair documentation accurately and comprehensively including work orders and logbooks in accordance to Shields Pharma policies, procedures, and applicable regulatory guidelines and standards.
• Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.
• Being able to meticulously evaluate and quantify various sources of error in measurement systems.
• Documenting any adjustments made to equipment and instruments during measurements and recording any deviations from standard procedures.
• Where applicable create and/or revise calibration and operation procedure/s.
• Support Quality Assurance investigations of instrument failures/breakdowns.
• Accurately and meticulously documenting calibration procedures, measurement results, and equipment maintenances in accordance to the company protocols and regulatory requirements and standards.
• Creating detailed reports and maintaining digital records of all measurements and analyses performed.
• Maintaining an inventory of standard measurement tools such as rulers, protractors, gauges, calipers, etc.
• Co-ordinating with vendors and system owners for quotes, scheduling, and troubleshooting for calibration, preventive maintenance, and qualification services.
• Train staff on proper operation and maintenance techniques of laboratory equipment and instruments to facilitate knowledge transfer contributing to the overall data integrity and quality management system of Shields Pharma
• Perform any other tasks/duties as assigned by departmental management.
  Job Requirements (Work Status, Qualification, Knowledge, Skills, and Experience)
  This position requires a blend of high technical expertise and interpersonal skills.

Senior Metrologist Must foster a collaborative environment while maintaining high standards of accuracy.

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship and live in Canada, preferably in Toronto area.
• 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 Canadian experience working experience in equipment and instrumentation, qualification, calibration, PM, trouble shooting, and repairs in pharmaceutical laboratory and production environment.
• Hands on in using a variety of hand tools, electric meters, calibration standards to perform essential day-to-day duties.
• Must be skillful in authoring and executing calibrations, preventative maintenance, repair work where applicable, and other service-related work and documentation.
• Must 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, dissolution, etc.
• Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
• Sound knowledge of Pharmaceutical regulation and guidelines including cGMP, EMA, FDA CFR 211, ICH, ALCOLA+, GAMP, NIST, ASTM as applied to equipment and instrument qualification, calibration and Preventative Maintenance.
• Be able to troubleshoot and repair complex systems and instruments
• Must be focused on problem at hand in a systematic manner and troubleshoot complex systems and instruments.
• Should be able to isolate problem, identify root cause/s, and resolve the issue in a systematic manner.
• Must demonstrate expertise in managing Metrology, Lab Systems maintenance, including any employees, contractors, and external vendors.
• Must demonstrate effective documentation practices supporting data integrity, facilitate knowledge transfer, and contribute to the overall quality management system of the company.
• Working knowledge of OSHA safe work practices.
• Must be comfortable working with Microsoft Office Applications, including Microsoft Word, and Excel
• Demonstrate strong people and interpersonal skills including being a team player, problem solver, active listener, easy to work with, etc.

Should demonstrate multi-tasking abilities working in a fast pace changing environment

• Must demonstrate clear, concise, and effective communication and written skills when describing technical matters or issues.
• Must be detail-oriented being focused on each project and be able to complete tasks efficiently.
• Should be able to clearly and neatly describe technical issues and be able to document work performed accurately in a technical manner.