Thermo Fisher Scientific Senior Validation Associate in Greenville, North Carolina
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
The Sr. Validation Associate role will apply Project Management and technical expertise within the pharmaceutical industry to successfully deliver CPV program goals and outcomes while interacting with customers and meeting their expectations. Continued Process Verification (CPV) is a global regulatory compliance requirement which focuses on ensuring product and process stability, control, and operation within the intended design space. This role will be a key part of the global CPV program dedicated to ensuring compliance and strong technical oversight of our products and processes.
Demonstrate highly effective oral and written communication skills and possess project management skills including the ability to engage the organization at multiple levels and organize CPV efforts.
Work with Business Managers and the business team with Technical Transfers, new business, or other situations as related to CPV.
Manage the scope, schedule, and reporting of CPV program activities for individual clients. Ensure status, risks, and open issues are tracked and that all stakeholders (Management, internal/external clients, BM/PM, and regulatory agencies) are informed in a timely manner.
Work directly with Product Management, Product Marketing, Engineering and other functional teams to ensure the successful implementation CPV monitoring programs and activities.
Serves as primary point of contact/communication for client projects for CPV program(s).
Clearly communicate goals and status updates to manager and project stakeholders.
Responsible to drive achievement of project milestones and deliverables for client CPV projects and site CPV goals.
Facilitate team meetings as needed on in-depth process and product analysis, risk assessments, decision-making, and other evaluations related to the CPV program.
Bachelor's Degree and 4-5 years of related experience in Pharmaceuticals, Project Management, Validation, or Statistics. OR Master's Degree with experience in in Pharmaceuticals, Project Management, Validation, or Statistics
Pharmaceutical industry experience highly preferred.
Solid technical background with understanding in at least once of the following areas is required: Biology, Chemistry, Engineering (Chemical/Process), or Mathematics.
H ands-on experience in Process Validation for Oral Solid Dose, Liquid and/or other product formulations in a GMP facility is preferred.
Demonstrated expertise in management of independent projects including timeline management, communication plans, risk plans, action item trackers, and project plans.
Experience is preferred using MS Project or equivalent as a tool to create timelines and monitor project progress.
Track record of working well in cross-functional environments, strong presentation and written/verbal communication skills.
Problem solver with ability to articulate program issues and drive to resolution.
Working knowledge in Basic Statistic and how to apply statistical analysis for process and product
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.