Engineer III, Process Validati Job in Wilson 27893, North Carolina Us
The Process Validation Engineer leads, coordinates, executes, and summarizes process
validation and cleaning validation activities.
• This position has no supervisory responsibility.
Supervisory
• Trains/mentors less experienced team members.
Trains manufacturing, laboratory, and other stakeholder groups on process and cleaning
validation protocols and Formula Manufacturing Records (FMRs) related to PV or CV studies
and PV or CV program procedures as required.
•
• Writes and reviews Engineering Studies or other protocols as required.
• Conducts periodic review of equipment/utilities qualification documentation.
• Conducts peer review of protocols and reports.
Documents sampling, performs testing, and documents test results throughout the stages
of production / unit operations as required by PV or CV protocols.
•
Leads assigned process validation and cleaning validation studies. Coordinates and
communicates with stakeholders to ensure accurately and timely completion of the studies.
•
Executes and documents study results for:Process validation protocolsCleaning validation
protocols
•
• Write and review cleaning validation (CV) study documentation, protocols and reports.
• Write and review process validation (PV) study documenation, protocols and reports.
BS and 4 years of related experience in Pharmaceutical or related industry or MS and 2 years
of related experience in Pharmaceutical or related industry or PhD and no significant
experience.
Sandoz is an equal opportunity employer, offering a robust and competitive benefits package to all employees, including medical and dental insurance, a generous 401K company match, tuition reimbursement, flexible spending plan, as well as wellness and prevention resources.
