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Job Location | Toronto |
Education | Not Mentioned |
Salary | Not Mentioned |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract |
Please note this position will be based on-site in Fort Worth, Texas.PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioningamp; 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 an experienced Automation Engineer for a project in the United States. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.Responsibilities: Convert manufacturing process instructions into automated solutions, likely involving software and hardware automation.Integrate Manufacturing Execution Systems (MES) at the L3 layer with Enterprise Resource Planning (ERP) systems. This may involve collaborating on L2 integrations and report development.Drive the testing and deployment of Opcenter software solutions, ensuring sufficient automated testing to maintain solution quality.Mentor and coach other technical team members on best practices and principles related to the role.Support the Product Owner in defining stories and acceptance criteria that are comprehensive and actionable for the development team.Evaluate vendor proposals, challenge costs and time estimates, and ensure that design and architecture align with the project #39;s needs.Demonstrate an understanding of key pharmaceutical niche processes, Pharma GxP regulations, and ISA-88/ISA-95 standards is important in this role.Requirements: A bachelor’s degree in engineering or technology.Able and willing to work and travel in the United States; successful candidates will be required to travel and work in the United States for an extended period; must possess Canadian citizenship and a valid passport.Three (3) years #39; experience in an Automation Engineering role.Lead and successfully delivered at least one Electronic Batch Record (eBR) project, which includes infrastructure setup, software installation, recipe development, and System Acceptance Testing (SAT) with users.Must have experience with Electronic Batch Record System Modeling specifically in the Siemens Opcenter platform.Practical hands-on experience with Siemens Opcenter is required.Experience in gathering requirements and translating them into a product vision, demonstrating expertise in development and engineering.Prior experience in a cGMP regulated industry an asset.Experience in application development, testing, and support based on Software Development Life Cycle (SDLC) methodology is necessary.Experience in GxP systems, Computer System Validation, and a consistent track record in supporting FDA regulated systems and business is preferred.Strong interpersonal skills are required, including excellent communication, networking, and influencing skills, with the ability to manage across all management and organizational levels.Verification experience associated with SQL server.FT View ME and FT View SE systems preferably related to drug product injectable operations, formulation, filling, or freeze drying.Why PharmEng TechnologyOur consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.What We offer:Comprehensive benefits packageamp; competitive wages.A supportive environment where employee growth is promoted.Paid holidays.Other great incentives.EEOC Statement:At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.