- September 30, 2024
- Greater Portland Area, OR, Information Technology(IT), Pharmaceuticals, Validation
7838 Validation Engineer
The Company needs Subject Matter Expertise (SME) in the area of validation supporting recipes and workflows and system setup/configuration to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite as it would enable reduced cost of ownership by the company, and harmonization of business processes between all sites that use the platform.
As the Syncade platform does not align with the DP network standard, a project must be executed as the site transitions from one MES platform to another.
The overall project duration is TO BE ADJUSTED.
Progress towards these above milestones will be checked at an agreed upon frequency and billed at that interval based on the work performed to ensure their realization.
Scope of Activities:
Develop proficiency for the company standard implementation of the PharmaSuite platform to enable better understanding for how to validate a multi-environment implementation, and some support for actual system configuration.
Develop proficiency in interfaces to the PharmaSuite platform, including warehouse management through the eWM module of SAP, SAP manufacturing, Mulesoft middleware layers, and communication to DeltaV, PI, and other manufacturing automation systems using industry-standard technologies (e.g. OPC.).
Develop understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables such as project and implementation plans, etc.
Start development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
Create, as directed by the company’s project-specific documentation required for implementation.
Creation and finalizing recipe requirement specifications for all recipes and workflows to be converted into PharmaSuite.
Developing validation test scripts for all system functionality (recipes, workflows, master data).
Finalizing and implementing in test, reference, and production environments final master data configuration.
Support validation activities, including authoring of test scripts, dry runs, and formal execution, as required to achieve project timelines.
Plan and implement project cutover solutions, and support the cutover of the system including activities occurring in the manufacturing space (e.g. deployment of printers, HMIs).
The hiring range for this position is $91 to $104 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.