Cambridge, Boston, MA, U.S.A.
Computer System Validation Expert
Due to a constant growth, PQE is looking for a new Senior Validation Specialist.
- 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
- 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
Our collaborators are engaged, developed, challenged and well-rewarded for performance.
We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.