Biopharmaceutical Commissioning & Qualification Engineer

Previous Pharmaceutical/Biotech experience is mandatory
12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry
Minimum 6+ years of direct C&Q experience with upstream or downstream bioprocess equipment/systems
Knowledge of requirements for cGMP operations, including SOPs, Change Controls, Validation
Experience with developing and executing validation projects
Ability to handle multiple projects and work in a fast-paced environment
Strong multi-tasking skills
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline

Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities
Lead the development of key qualification deliverables during the project lifecycle
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates
Engage other departments, as required, for design reviews and decisions
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs)
Work may require occasional support over shutdowns or extended hours
Client-management (maintain key Client relationships in support of business development and pursuit of new work)
Supervise contractors during critical testing of systems and equipment
Other duties as assigned by client, and/or MMR, based on workload and project requirements

Experience with Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ
Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both)
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys)
Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation
Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports