Technical Qualification Project Manager

Pharma Quality Europe - Rockville, MD

Full-timeEstimated: $82,000 - $110,000 a year
Skills

PQEis a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds 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. Further information can be found at www.pqegroup.com.

Due to a constant growth, PQE is looking for a new Technical Qualification Project Manager.

Responsibilities include, but are not limited to, the following:

  • 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 EU and US GMP

Requirements:

  • Full availability to travel domestically and abroad: up to 70%
  • Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
  • Minimum of 3 years’ experience in the drug manufacturing area, especially in the Qualification area (Equipment, Machinery, Utilities)
  • Integrity, strong analytical skills and attention to detail

Job Type: Full-time

Experience:

  • Project Management: 5 years (Required)

Location:

  • Rockville, MD (Required)

License:

  • Driver's License (Required)

Language:

  • English (Required)

Work authorization:

  • United States (Required)

Required travel:

  • 75% (Required)