Technical LIMS Computer Scientist (cGMP Focus)

at  Pharmeng Technology Inc

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, 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 seeking a highly skilled and technical LIMS Specialist with a strong understanding of cGMP (Good Manufacturing Practices) to join our team in Toronto, Ontario. This role requires an individual who is not only adept in programming and system customization but also has a solid grasp of data governance, data integrity, and compliance within a pharmaceutical or biotech environment.

REQUIREMENTS:

• Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
• Extensive experience in LIMS customization and configuration within a pharmaceutical or biotech environment.
• Strong understanding of cGMP and regulatory compliance requirements.
• Proficiency in programming languages relevant to LIMS customization.
• Excellent project management and organizational skills.
• Ability to work collaboratively with cross-functional teams and manage relationships with internal stakeholders.
• Experience in data governance and maintaining master data integrity.
• Familiarity with testing data models for managing data generated by QC laboratory instruments, TCU, and computerized systems.

PREFERRED QUALIFICATIONS:

• Previous experience working with LAB MASTER or similar clinical laboratory software.
• Knowledge of integrated quality management systems for management of master data.
• Experience in participating in regulatory inspections and internal audits is a bonus.
• Strong communication skills and the ability to foster transparent sharing of scientific and testing data semantics.