Validation Engineer / Consultant

Omni Consulting Services is a leading staffing firm focused in life science industry, we primarily serve biotech-pharma clients. Our services range from CQV, compliance, process-utilities engineering, project management, regulatory affairs and digitalization. This women- and minority-owned business is established in 2019 and encourages a work-family like culture. At Omni, we embrace diversity including everyone’s unique skills. Omni truly believe to grow together with our employees and clients; our employees are our assets!

We are looking for process / utility engineer with design, automation, commissioning, qualification, validation and start-up of various processes, systems and facilities. A combination of strong technical aptitude, interpersonal skills and technical writing with quality mindset are the desired skill set.

This is an excellent opportunity to join our growing team!

Responsibilities

• Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process systems, process equipment and utility systems following client procedures and good documentation practices
• Temp. mapping or CQV experience is a must.
• Experience with gene therapy / cell therapy is a plus.
• Assist in deviation root cause analysis and corrective action plans.
• Generate final and summary reports for executed test protocols
• Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met. 
• Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports. 
• Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities. 
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT 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.

Qualifications

• 1 to 2+ years of experience in biotech, pharmaceutical, medical device, or academic or environment
• Experience writing and executing commissioning, verification, and validation protocols and associated reports
• Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
• Experience utilizing risk based methodologies in testing
• Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
• Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air
• Experienced with Office software such as Word and Excel
• Experience with testing equipment and software such as Kaye Validators and Dataloggers
• Engineering or Scientific degree
• Travel may be required on occasion

Candidates please note:  This job description is not all inclusive, other duties may be required, as assigned. Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Canada or Europe are encouraged to apply.