Biopharmaceutical Commissioning & Qualification Engineer/Specialist

Biopharmaceutical Commissioning & Qualification Engineer/Specialist

Requirements

• Previous Pharmaceutical/Biotech experience is mandatory
• 8+ 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
• Excellent written and spoken English is required including the preparation of technical documents in English
• Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline

Responsibilities

• 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 to ensure project is well defined, and the action plan to test the system is applicable and relevant
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met
• 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, specifically during installation and commissioning / validation phases
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements
• Supervise contractors during critical testing of systems and equipment
• Other duties as assigned by client, and/or MMR, based on workload and project requirements

Preferred Qualifications

• Experience with C&Q parts washer and autoclave is required
• Experience with C&Q of other process equipment, utilities, facilities is an asset
• Thermal Validation experience is an asset
• Experience with developing and executing validation projects
• Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues
• Possess mentorship skills, to coach and develop junior and intermediate employees
• Ability to handle multiple projects and work in a fast-paced environment
• Strong multi-tasking skills