0821 MES Training and Change Lead
Description:
The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing.
We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies.
As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently.
You will play a crucial role in supporting the multi-phase deployment of MES; this role offers a dynamic range of responsibilities where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need.
Responsibilities:
As the Training and Change Lead, you will support the project in three critical areas:
Training:
Create a training/onboarding plan for the MES to support existing job roles.
Work with business SMEs to create new training material and revise existing training material tailored to job functions and business needs.
Support business functions to ensure access and compliance with new systems by developing, executing and supporting instructor-led trainings at the site.
Evaluate existing platform training options for applicability and usage for MES implementation.
Collaborate with local training team to ensure seamless knowledge transfer to sustain the platform post Go Live.
Documentation Support:
Work with business SMEs to identify and update documentation (e.g. SOPs, MBRs, forms, ect) which are impacted as part of the MES implementation utilizing existing GMP document management systems.
Work with local stakeholders and the project team to ensure accurate and timely changes are made.
Collaborate with compliance, quality and other core team members to identify and assess project risks.
Change Management:
Execute change management plans that align with business objectives.
Collaborate with MES core team project to refine and execute on project deliverables.
Identify and mitigate risks associated with organizational change as a result of the MES implementation.
Collaborate with project manager on communication strategy and execution.
Who you are:
The ideal candidate brings:
A Bachelor’s degree and at least 2 years of relevant cell and/or gene therapy industry experience.
Experience in formal change management processes.
Experience with technical writing, especially with regulatory compliance and GMP considerations in mind.
Experience with data analysis software, ERP systems, Manufacturing Execution Systems, and quality management systems.
Experience developing training and assessing training outcomes in a GMP setting
(Preferred).
Some exposure to benchwork/lab work (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc.).
Role is expected to be in person and primarily onsite in Hillsboro, OR.
The hiring range for this position is $51.00 -$61.00 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on 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.