Validation Associate

Location

Round Lake, IL | United States

Job description

Stefanini Group is hiring!

Stefanini is looking for Validation Associate in Round Lake, IL Location

For quick Apply, please reach out to Michael Miller- call:

(828) 750-5444

Work Hours: M-F (40 hours)

Work Location: Round Lake, IL

Shift: 1st Shift

Must not be allergic to Cephalosporins or Penicillin.

This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions and made available as needed during FDA and client/customer compliance audits.

• Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
• Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
• Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.
• Serves as a project lead for projects of intermediate scope with cross-functional teams.
• Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Job tags

Salary

$50 - $55 per hour