Process / Utilities / Facilities Engineer / Senior Engineer (Biotech)

Omni Consulting Services is a leading engineering and CQV consulting firm providing expertise to the pharmaceutical and biotechnology industries. 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 believes to grow together with our employees and clients; our employees are our assets! 

Omni's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

We are looking for process engineers with experience in process design and engineering documentations for bio-pharma key process and process utilities equipment. The candidate will work with a group of engineers involved in 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 a quality mindset are the desired skill set.

This is an excellent opportunity to join our growing team!

Responsibilities

• Provide technical leadership on design, commissioning and start-up of various processes, systems and facilities. Undertake technical reviews for documents generated by others to ensure that technical and regulatory requirements are met.
• Working with full range of Biotech/pharma project phase execution including all design phases (conceptual design, basic design, detailed design), construction support and commissioning. You may support CQV (Commissioning, qualification and validation), shut-down, and project hand-over activities. 

• Can include process equipment and facility engineering, design, integration, documentation specification and validation.

• Generation of engineering specifications and drawings (FRS, URS, SOO, P&IDs), review of engineering documents. Experience with either process equipment/systems such as: buffer tank, media tank, CIP, pH adjust skid, fermentors, chromatography systems, high purity water and steam systems), control systems, vial and syringe filling equipment, Isolators, Or utilities / facilities systems: WFI, gases (PA, N2, O2 etc.), HVAC etc.

• Oversight and management of process engineers, provide guidance and leadership to colleagues in technical aspects, thoroughness and detail oriented in ensuring fulfillment of project deliverables of team.

• 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 Omni 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

• 3 to 6 years of experience in biotech-pharmaceutical academic or industrial environment

• Led projects as technical lead(s) for mid to large projects involving multiple process units with a significant degree of complexity

• Experienced with upstream and downstream bioprocess operations, and fill-finish systems, or utilities facilities systems

• Demonstrated experience with manufacturing processes and equipment such as CIP systems, buffer tank, media tank, and pH adjust skid equipment

• Provide leadership and expertise in capital projects and development of project design phases (conceptual design, basic design, detailed design) and commissioning

• Experienced with software such as AutoCAD, Schedule Pro/Super Pro or other similar process simulation and scheduling software is a plus

• Engineering degree in Chemical Engineering, Biochemical Engineering or Mechanical Engineering

Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design and engineering is a MUST. Candidates with direct related experience interested in US or Canada are encouraged to apply.