Morgantown - WV, USA
PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 600 dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Due to a constant growth, PQE is looking for a Validation Engineer/ Consultant based in US, available to join one of our local Qualification projects in Morgantown.
- Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
- Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
- Development of thermal validation study protocols
- Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)
- Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
- Coordination of junior resources for qualification testing execution and use of test instruments
- Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)
- Development of calibration and maintenance plans and related instructions
- Development of standard operating procedures
- Advanced knowledge of local GMPs
- QC Lab Instruments qualification (T/rH validation studies mainly)
- validation of related control systems according to GAMP V-model
- ERES compliance assessment/verification per 21 CFR Part 11 ERES
- Development of Interim Controls complying with ALCOA+ Data Integrity principles.
Responsibilities will include, but not limited to, the following:
- Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
- Minimum of 10 years’ experience in the drug manufacturing area - Equipment and Utilites validation
- Integrity, strong analytical skills and attention to details
- Valid US work permit
If interested, please send your resume clicking the button on the left of this page.
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.