Job Description

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 abuse.

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, Continuous Training and skill development.
At Shields Pharma, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are currently looking for the following individuals to join our growing team!

Position Title

: Computerized Systems and Security Specialists (Full-time) - 2 Positions

Reports To:

V.P. of Operation

JOB SUMMARY

The IT and Security Specialist supports all departments within Shields Pharma Inc. and is well-versed in current software and technological trends in traditional visual effects workflows, as well as next generation software, hardware and cloud services related to content creation and virtual production following internal procedures and Good Manufacturing Practices (GMP).

The IT and Security Specialist will provide strategic and operational leadership for all IT systems supporting production, Quality Control laboratory, Pharmaceutical Science and Technology, and Research and Development (R&D) across Shields Pharma Inc. operation. This role is responsible for aligning technology capabilities with business needs, ensuring regulatory compliance, optimizing digital transformation initiatives, and driving innovation across end-to-end to processes.

ROLES AND RESPONSIBILITIES

(including, but are not limited to)

Conduct implementation, enhancement and support of Agilent Open Lab CDS with ECM XT Server, Client and Instrument Configuration, Agilent Cary WinUV Server and Client, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Madgetech 4 secure software, and Microsoft Domain Network Server, Microsoft Dynamics 365 (D365), and other core platforms. Performing preventive maintenance and troubleshooting of Shields Pharma computerized controlled systems Maintain high system availability, performance, and data integrity across all supported platforms. Support lifecycle management and validation of computerized systems in compliance with GxP and 21 CFR Part 11. Ensure IT systems meet global regulatory requirements, including GxP, GMP, GLP, GDPR, and ALCOA+. Analyze user requirements and design and develop Shields Pharma Inc. Network System Architecture (NSA) and specifications. Collaborate with Quality and Compliance teams to ensure readiness for regulatory audits and inspections. Oversee governance, risk management, cybersecurity and business continuity plans across supported functions. Collaborate with all departments and functional teams to ensure IT goals and objectives are aligned. Collaborate with Operations and Quality to develop key performance indicators (KPIs) for balanced scorecard reporting. Ensure compliance with security requirements, including phishing awareness training, cybersecurity training as required, and onsite physical security (cameras). Validate all laboratory and production equipment software, including maintenance of the Computerized System Master Validation Plan, risk assessment, compliance with 21CFR Part 11 and GMP standards. Develop validation protocols where not provided by vendors and execute validation protocols. Develop and implement policies and procedures throughout the software development life cycle to maximize the efficiency, effectiveness, and overall quality of software products and information systems. Create SOPs pertaining to IT systems and write and review related technical documents and standard operating procedures. Perform all work in compliance with GMP, company SOPs, policies and regulatory and safety standards. Assess physical and technical security risks to data, software, and hardware Develop policies, procedures, and contingency plans to minimize the effects of security breaches. Manage all matters related to physical access to the facility and provide specific access to employees as defined by department heads. Ensure the maintenance of IT infrastructure, Corporate Network performance, software and computer-related hardware. Conduct computerized system backups and data recovery processes. Manage SPI Corporate Network, including user administration, network security, etc*.
Review and modify standard operating procedures (SOPs) Develop and review deliverables of the Software Development Life Cycle (SDLC), such as validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ and PQ), qualification reports. Execute, and/or review qualification protocols to ensure compliance and adherence to applicable guidelines. Perform a risk analysis and define the qualification process Manage instrument software versions and releases. Guide internal departments on how to use technology efficiently. Work closely with department heads and HR to understand and forecast future technology needs, offer solutions, and deliver high levels of IT support. Identify solutions to recurring IT issues and minimize technical limitations experienced by staff, allowing them to work without disruption. Provide user data or any other requested data to the VP of Operations, including software/licensing needs. Manage software licensing in collaboration with QA, QC and Finance. Monitor and report IT budgets to assess technological performance. Perform other related duties as assigned based on company needs.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Master's or Bachelor's degree in computer science or Information Systems (security, infrastructure, software) or related field Minimum of 5 years of direct experience in the pharmaceutical information technology space. Minimum of 3 years of direct and hands-on experience working experience in computerized systems qualification, calibration, PM, trouble shooting, in a pharmaceutical laboratory and production environment. Familiar with a variety of hand tools, electric meters and calibration standards to perform essential day-to-day duties. Strong knowledge and understanding of computer systems, software development and IT infrastructure. In-depth understanding of validation principles, risk assessment, and compliance with pharmaceutical regulatory standards such as 21CFR Part 11, ALCOA+, GXP and GMP. Experience in developing and executing validation protocols for laboratory and production equipment software. Proficient in developing policies, procedures, and standard operating procedures (SOPs) for IT systems. Familiarity with software development life cycle (SDLC) and quality assurance processes. Excellent knowledge of data security principles, risk assessment, and the development of security policies and procedures. Strong understanding of networking, network security and system architecture. Experience in managing software qualifications, licensing and software versions. Proven track record of improving efficiencies and reducing costs related to software and IT systems. Familiarity with industry-standard software and systems such as Agilent Open Lab CDS, Agilent Cary WinUV, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Microsoft Domain Network, Microsoft SQL Server, Desktop Virtualization (VMWare), WAN, LAN, VLAN, TCP/IP, CDP, RIP, RIPv2, Access Control List (ACL), Network Address Translation (NAT), Port Address Translation (PAT), ATM, GPON, MPLS, Multicast, VPN, VOIP and IP CCTV System. Strong analytical and problem-solving skills to identify and resolve recurring IT issues. Excellent communication and interpersonal skills to collaborate with department heads, HR and senior management. Familiarity with IT budgeting and financial reporting. Knowledge of backup systems and data recovery processes. Continuous learning mindset to stay updated with advancements in technology and industry best practices. Demonstrate strong people and interpersonal skills including being a team player, problem solver, active listener, easy to work with, etc. 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. Able to clearly and neatly describe technical issues and be able to document work performed accurately in a technical manner. Demonstrate multi-tasking abilities working in a fast pace changing environment

How To Apply

Please reference "Computerized Systems and Security Specialist" in subject line and submit resume with cover letter to HR@shieldspharma.com

The information collected to review your application will be processed by the human resources services.

We are committed to adhering to our company objectives and requirements outlined for each position.

We welcome and encourage all applicants for their interest. However, only those applicants that are qualified shall be contacted for interview.

No phone calls please.

Thank You

Kindly refrain from applying if you are not fully qualified (i.e.,_

work status in Canada, Qualification, Years of Experience, Industry knowledge, and related skills).

_

Shields Pharma Inc.

60 Shields Court
Markham, Ontario
Canada L3R 9T5
www.shieldspharma.com

Job Type: Full-time

Benefits:

Dental care Extended health care Life insurance On-site parking Vision care
Application question(s):

Master's or Bachelor's degree in computer science or Information Systems (security, infrastructure, software) or related field Minimum of 5 years of direct experience in the pharmaceutical information technology space Minimum of 3 years of direct and hands-on experience working experience in computerized systems qualification, calibration, PM, trouble shooting, in a pharmaceutical laboratory and production environment. Familiar with a variety of hand tools, electric meters and calibration standards to perform essential day-to-day duties. Strong knowledge and understanding of computer systems, software development and IT infrastructure In-depth understanding of validation principles, risk assessment, and compliance with pharmaceutical regulatory standards such as 21CFR Part 11, ALCOA+, GXP and GMP Experience in developing and executing validation protocols for laboratory and production equipment software. Familiarity with software development life cycle (SDLC) and quality assurance processes Excellent knowledge of data security principles, risk assessment, and the development of security policies and procedures. Experience in managing software qualifications, licensing and software versions Proven track record of improving efficiencies and reducing costs related to software and IT systems Familiarity with industry-standard software and systems such as Agilent Open Lab CDS, Agilent Cary WinUV, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Microsoft Domain Network, Microsoft SQL Server, Desktop Virtualization (VMWare), WAN, LAN, VLAN, TCP/IP, CDP, RIP, RIPv2, Access Control List (ACL), Network Address Translation (NAT), Port Address Translation (PAT), ATM, GPON, MPLS, Multicast, VPN, VOIP and IP CCTV System.
Work Location: In person

Application deadline: 2025-09-19
Expected start date: 2025-09-19