PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 500 dedicated consultants, PQE delivers the highest level of expertise to more than 200 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. Further information can be found at www.pqe.eu.
Due to a constant growth, PQE is looking for SME in facilities, process equipment, utilities and related control systems qualification in the pharmaceutical regulated environment.
Responsibilities may include, but are not limited to, the following:
Key technical skills:
- Development of qualification plans, user/technical requirements specifications, design qualification plans/protocols/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.: ASTM, ISPE, GAMP)
- Development of pharmaceutical processes flow charts, risk assessment, and validation plans/protocols
- Development of cleaning validation strategies, risk assessment, plans and protocols
- 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)
- Development of risk-based technology transfer plans, protocols and summary reports
- Deep knowledge of ASTM E2500 standard for specifications, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment
- Consolidated expertise in the validation of pharmaceutical sterile and/or oral solids and/or biotech manufacturing processes and cleaning instructions will be considered as preferable skills, as well as the coordination of project streamlines, in terms of timeline, resources and budgets management.
Nice to have technical skills:
- 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 EU and US GMP
- Fluent English
- Technical Degree (Engineering, Chemistry, Pharmacy, Informatics, Physics)
- Minimum of 3 years experience in the drug manufacturing area
- Availability to travel
- Integrity, strong analytical skills and attention to details Fluent in other languages (German, Spanish, Chinese)
Work Location: Florence, Italy
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.
Job Type: Full-time