The essential functions of this position include but are not limited to:
Manage, implement, and continuously improve the site validation, FMEA, control plan, change control and other process control systems and ensure compliance with corporate and global standards and policies.
Ensure validation support structure and document handling system are developed and maintained and continuously improved
Provide timely and comprehensive reviews of technical documentation (change controls, validations, studies, etc.).
Host training and educational sessions for validation, change control, and process control. Track and training of associates at the site, ensuring that training requirements are defined, and completed at the site. Establish mentoring processes to improve effectiveness of validation work
Establish and maintain tracking of process control records; e.g. change control, protocols, completion reports, FMEA's, Control Plans, including ownership of the Validation Master Plan (VMP) and Validation Tracking Schedule (VTS)
Implement electronic solutions and associated projects for responsible areas as opportunities arise
Communicate site activities and metrics regarding process control to site leadership
Develop and maintain validation procedures and related local records, ensuring their compliance with global standards and corporate procedures
Develop and maintain metrics to identify areas for continuous improvement
Participate on Validation Council or similar corporate initiatives
Participate in audits and inspections as a subject matter expert
Lead and/or participate in problem solving, lean, six-sigma, or related events.
Provide data analysis and statistical guidance, assisting in experimental design (DOE) and coordination of engineering studies.
Support plant Safety initiatives.
Minimum Requirements
Degree level qualification; or equivalent combination of education and experience.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
IT Services and IT Consulting
Referrals increase your chances of interviewing at VIR Consultant LLC by 2x