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Added 5 hours ago
NF
Lead Project Engineer
New Flyer
Winnipeg, MB
- Full-time
Provides required engineering support to Production, Quality Assurance, Customer Service Support and other departments as required
Added 5 hours ago
TT
Principal Engineer
Tundra Technical Solutions
Markham, ON
- $90 to $105 CAD / hour
- Contract
Our client is seeking a senior, hands-on Principal Software Engineer to help shape and deliver the next generation of its enterprise technology landscape.
Added 5 hours ago
RC
Senior AI Engineer
Realtek Consulting LLC
Toronto, ON
- Contract
Practical experience evaluating non-deterministic systems: test design, quality scoring, regression suites, and translating evaluation into business-ready acceptance criteria.
Added 5 hours ago
Q
Junior Software Quality Engineer
Quadient
Vancouver, BC
- $65,000 to $75,000 CAD / year
- Full-time
As a Software Quality Engineer on our Integration team, you'll own the quality of the integrations that connect our Accounts Payable platform with the different ERP and accounting systems…
Added 5 hours ago
CO
Project Manager (Infrastructure & Facilities)
City of Red Deer
Red Deer, AB
- $97,718.4 to $122,148 USD / year
- Full-time
The Project Manager/Engineer reports to the Capital Projects Engineer in the planning and delivery of municipal capital projects and municipal facility upgrades as assigned. This includes…
Added 5 hours ago
CC
Senior Roads Designer
Crozier: Consulting Engineers
Burlington, ON
- Full-time
In this role you will work closely with a multi-disciplinary team to develop creative, high-quality design solutions from preliminary design through detailed design, tender and construction.
Added 5 hours ago
G
Remote Operations Engineer
Graymont
Moncton, NB
- Full-time
…kilns) and atmospheric lime hydrators. The Remote Operations Engineer fills a crucial role in ensuring safe & continuous operation, product quality, and compliance with environmental…
Added 5 hours ago
T
Oracle Fusion HCM Techno functional Consultant
TechDoQuest
Brampton, ON
- Contract
We are seeking a highly skilled Technical Support Engineer with a strong background in Oracle Cloud HCM and Payroll. The ideal candidate will possess a techno functional expertise in Oracle…
Added 5 hours ago
S
Senior Java Backend Engineer
Synechron
Montreal, QC
- Full-time
…improvements. The candidate will be responsible for delivering high-quality, scalable, and maintainable Java solutions, collaborating closely with team members and stakeholders, and…
Added 5 hours ago
T
Quality Engineer II
TD
Toronto, ON
- Full-time
Senior hands-on quality engineering leadership for Payments Global Transfer current state applications and modernization initiatives
Added 5 hours ago
Senior Mechanical Engineer - ENG4 - HC
WF Group Inc.
Hamilton, ON
The Senior Mechanical Engineer is responsible for planning and conducting assignments with a high level of specialization and autonomy. This role involves solving complex engineering…
Added 5 hours ago
W
Lead Professional, Welding Engineering
WSP
Cambridge, ON
- Full-time
…technical leadership, guide multidisciplinary teams, champion quality and safety, and help deliver innovative solutions that create lasting value for clients and…
Added 5 hours ago
KC
Forward Deployed AI Engineer
Keyrus Canada
Toronto, ON · Montreal, QC
- Full-time
We are currently building our talent pipeline for upcoming Forward Deployed AI Engineer opportunities in Canada. While we may not have an immediate opening today, we are actively connecting…
Added 5 hours ago
C
Senior Java Engineer Tech Lead - Vice President
Citi
Mississauga, ON
- Full-time
We are seeking an experienced Senior Java Engineer, Tech Lead with strong expertise in Java, Apache Spark, Hadoop ecosystem, Hive, Databricks, and large-scale data processing platforms. The…
Added 6 hours ago
AE
Jr Project Engineer/EIT
Acero Engineering
Calgary, AB
- $30 to $40 CAD / hour
- Full-time
…enthusiastic individual to fill a permanent role as a Junior Project…
Added 6 hours ago
OL
Junior Mechatronics Engineer
OTI Lumionics Inc.
Mississauga, ON
- Full-time
Added 6 hours ago
EV
Engineer, Mechanical
Elk Valley Resources
Sparwood, BC
- $108,000 to $145,000 CAD / year
Reporting to the Senior Engineer Supervisor, the Engineer, Mechanical, Water Operations, is focused on design, troubleshooting and optimization of water treatment facilities in the Elk…
Added 6 hours ago
EV
Engineer or Engineer in Training, Mechanical
Elk Valley Resources
Elkford, BC
- $91,300 to $126,800 CAD / year
Reporting to Senior Engineer, Maintenance, the Engineer / EIT, Mechanical is responsible
Added 6 hours ago
W
Senior Project Manager – Power Delivery
WSP
Quebec, QC
- Full-time
Ensure engineering deliverables meet quality expectations, client requirements, and applicable regulatory standards.
Added 6 hours ago
EI
Electrical Engineer - Traffic Signal
Egis in Canada
Toronto, ON
- $120,000 to $150,000 CAD / year
- Full-time
Electrical Engineer – Traffic Signal Design is a technical leadership role supporting multidisciplinary transportation infrastructure projects in Toronto, Ontario, Canada. The position is…
Added 6 hours ago
EI
Electrical Traffic Signal Designer
Egis in Canada
Toronto, ON
- $80,000 to $120,000 CAD / year
- Full-time
The position participates across project delivery phases including detailed design, field investigation, design review, quality assurance, construction support, stakeholder coordination,…
Added 6 hours ago
AC
Product Development Engineer - Mechanical Design For Liquid Cooling
Amphenol Communications Solutions
Markham, ON
- Full-time
Position: Product Development Engineer - Mechanical Design for Liquid Cooling
Added 6 hours ago
MG
Ingénieur(e) d'usine / Plant Engineer
Medicom Group
Saint-Eustache, QC
- Full-time
Added 6 hours ago
EV
Engineer or Engineer in Training, Mechanical
Elk Valley Resources
Elkford, BC
- $91,300 to $126,800 CAD / year
- Full-time
Reporting to Senior Engineer, Maintenance, the Engineer / EIT, Mechanical is responsible
Added 6 hours ago
TH
Supervisor Mechanical Maintenance Caster MS 185251
The Heico Companies LLC
L'Orignal, ON
- Full-time
…equipment maintenance at the Plant in order to meet safety, quality, efficiency, cost and service…

Stark Associates LLC

Industrial Automation And Computer System Validation Engineer

Cambridge, ON, Canada

Contract

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Job details

Job type: Contract
Apply by: Nov 12, 2026
Posting language: English
Posted: Oct 13, 2026

Original job description

Company Description Stark Associates LLC is a specialized global Healthcare and IT solutions company serving leading life sciences organizations across the pharmaceutical, medical device, biotechnology, consumer healthcare, and cosmetics sectors. Headquartered in New Jersey, USA, with operations in Hyderabad, India, Stark Associates supports the entire product development value chain, from drug discovery through post-marketing services. The company delivers flexible outsourcing models that combine onshore and offshore capabilities to meet diverse client requirements. Stark Associates partners with an extensive portfolio of life sciences clients, including FDA/EMA-approved CROs and several top-ranked global pharma, biotech, generic, and medical device companies. Team members join a dynamic environment focused on high-quality, compliant, and innovative solutions for regulated industries.
Role Description The Industrial Automation and Computer System Validation Engineer is a contract, on-site role based in Cambridge, ON. This role is responsible for designing, implementing, and supporting industrial automation systems used in manufacturing and laboratory environments, ensuring they meet regulatory and operational requirements. Daily activities include developing and executing computer system validation (CSV) protocols, documenting system lifecycle deliverables, and performing risk assessments for GxP-relevant systems. The engineer collaborates with cross-functional teams to troubleshoot automation and control systems, optimize system performance, and maintain compliance with FDA, EMA, and other regulatory guidelines. The role also involves supporting audits, preparing technical documentation, and providing training and guidance on automation standards and validation best practices.
Qualifications

Strong background in industrial automation and control systems (e.g., PLCs, SCADA, DCS) and experience integrating these systems within manufacturing or laboratory environments.
Hands-on computer system validation experience in regulated life sciences settings, including development of IQ/OQ/PQ protocols, validation plans, reports, and risk-based validation approaches.
Knowledge of GxP, 21 CFR Part 11, data integrity principles, and relevant FDA/EMA guidelines, with the ability to apply these regulations to automation and computerized systems.
Proficiency with system documentation and technical writing, including user requirements, functional specifications, design specifications, test scripts, and standard operating procedures.
Ability to analyze complex technical issues, perform root cause investigations, and implement corrective and preventive actions for automation and validation-related problems.
Bachelor’s degree in Engineering (Electrical, Automation, Computer, or related field), Computer Science, or a comparable technical discipline; advanced degree or specialized certifications (e.g., ISPE, GAMP, CSV) are an asset.
Experience working in pharmaceutical, biotech, or medical device manufacturing environments, preferably with exposure to global quality systems and audit processes.
Effective collaboration and communication skills, with the ability to work on-site

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More about this job

Responsibilities

Design, implement, and support industrial automation systems in manufacturing and laboratory environments, while developing and executing computer system validation protocols and lifecycle documentation. Troubleshoot and optimize systems, assess risks, support audits, and maintain compliance with applicable regulatory requirements.

Requirements

Requires a technical bachelor’s degree or comparable discipline, hands-on computer system validation experience in regulated life sciences, and a strong background in industrial automation and control systems. Candidates should know GxP, 21 CFR Part 11, data integrity, validation documentation, and risk-based approaches, with relevant manufacturing experience and strong collaboration skills.

Skills

Industrial Automation
Control Systems
PLC
SCADA
DCS
Computer System Validation
IQ/OQ/PQ Protocols
GxP Compliance
21 CFR Part 11
Data Integrity
Risk Assessment
Technical Documentation
Root Cause Investigation
Corrective and Preventive Actions
Audit Support
System Integration

Visa sponsorship

Not detected in the job text

Keywords

Industrial Automation
Computer System Validation
PLC
SCADA
DCS
GxP
21 CFR Part 11
FDA
EMA
IQ/OQ/PQ
Validation Plans
Validation Reports
Risk-Based Validation
Data Integrity
User Requirements
Functional Specifications
Design Specifications
Test Scripts
Standard Operating Procedures
Root Cause Analysis
Corrective and Preventive Actions
Audit Support
Pharmaceutical Manufacturing
Biotechnology
Medical Device Manufacturing
GAMP
ISPE

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