Responsibilities:

• Evaluate qualification and validation projects to establish technically and scientifically sound protocols and test plans.
• Execute protocols by carrying out the preapproved testing in the operations and laboratory areas.
• Collect and analyze all data, write final report and obtain approvals.
• Review technical documentation (batch records, SOPs, calibration records, preventive maintenance, work orders, protocols, reports) for continuity and accuracy.
• Perform gap assessments and remediation as required on legacy qualification and validation packages.
• Write SOPs and protocols to support departmental programs and projects.
• Evaluate, maintain and operate validation instrumentation as required in order to support assigned projects (examples: Kaye Validator 2000, dew point monitor).
• Coordinate successful execution of projects by working effectively with cross-functional groups.
• May be involved in investigation and root cause analysis for incidents reported on validated systems
• Other duties, as assigned

Qualifications/Requirements:

• Technical Bachelor’s degree in a scientific discipline, or equivalent experience
• 5+ years of experience in pharmaceutical industry
• Ability to work harmoniously and effectively with others in a fast-paced environment.
• Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
• Flexibility to work off-hours and weekends as required to support manufacturing plant projects
• May be required to move about the facility
• May be required to remain sedentary for periods of time

Full-Time Job