Training and Change Lead, Manufacturing Execution System (Hillsboro, OR)

For more than 40 years, our Customer has been following science and seeking solutions to unmet medical needs. They are a biotechnology corporation that makes medicines to treat patients with serious medical conditions. Their goal is to use the power of genetic engineering and advanced technologies to make medicines that address unmet medical needs, and help millions of people worldwide.

We are seeking a MES Training and Change Lead on a contract basis to help support our Customer's business needs. This role is onsite in Hillsboro, OR.

This role will play a crucial role in supporting the multi-phase deployment of Manufacturing Execution System (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

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
  
  

Skills And Qualifications

• 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.)
  
  

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)

Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.