Biopharmaceutical Senior Validation Engineer/Specialist

Previous Pharmaceutical/Biotech experience is mandatory
8+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry
Experience with commissioning & qualification of equipment & facilities is required
Engineering degree, preferably in Mechanical, Electrical or Chemical
Ability to handle multiple projects and work in a fast-paced environment
Strong multi-tasking skills

Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities
Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle
Able to perform field execution of qualification test cases and protocols
Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant
Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates
Engage other departments, as required, into design reviews and decisions
Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs)
Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases
Visit construction and installation sites, wearing necessary safety PPE
Supervise contractors during critical testing of system and equipment
Other duties as assigned by client, and/or MMR, based on workload and project requirements
Lead/Mentor a team of validation engineers/specialists

Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required
Experience with commissioning & qualification of biotech process equipment, such as fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset
Experience with Qualification or Validation of clean utilities and ISO clean rooms
Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
Leadership is considered an asset, but not required