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
