Operations Senior Specialist

Role overview

The Operations Senior Specialist will help build and put into practice biologics and vaccine manufacturing capabilities by connecting process engineering, facility design, and operational preparedness. This position supports the definition of processes and front-end engineering work so that process needs are properly reflected in equipment choices, facility planning, and operating workflows. It also contributes to readiness activities and technology transfer.

Process engineering and design support

• Create and review process flow diagrams, process narratives, and mass and volume balances for biologics manufacturing using information received from the sending unit.
• Convert process needs into equipment sizing, technical specifications, and input for facility design.
• Help develop user requirement specifications and technical requirements for process equipment and production areas.
• Take part in design reviews to confirm that process requirements match the facility layout, cleanroom zoning, and utility systems.
• Assist in assessing process technologies, single-use systems, and equipment setups.

Front-end engineering and RFP support

• Prepare technical RFP and RFQ packages by consolidating process and operational requirements.
• Support the creation of process data sheets, technical inputs, and assessment criteria.
• Coordinate vendor questions, clarifications, and bid-related documentation.
• Review and organize vendor submissions and technical proposals for internal assessment.
• Track RFP schedules, deliverables, and evaluation inputs.

Operational support

• Support execution of the operational readiness plan for a greenfield manufacturing site.
• Assist in technology transfer activities so the transferred process remains aligned with site capabilities.
• Participate in coordination meetings and keep action trackers updated across workstreams.
• Help prepare for process validation and regulatory inspections.

Education and experience

A bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a closely related scientific discipline is required. Practical experience or formal training in pharmaceutical manufacturing or biotechnology is mandatory.

The role calls for 5 to 6 years of experience in pharmaceutical or biopharmaceutical manufacturing settings, with exposure to process engineering, MSAT, or manufacturing support functions. Experience with facility design, equipment specification, or engineering projects is expected, along with familiarity with GMP environments and drug product manufacturing operations. Prior work involving RFP processes, vendor coordination, or technical document preparation is required. Exposure to cell and gene therapy is an added advantage. Experience in project management or capital projects, especially in coordinating cross-functional teams, is highly desirable.

Skills and knowledge

The ideal candidate should understand biologics and/or vaccine drug product fill-finish manufacturing and be able to translate process needs into equipment and facility design requirements. Knowledge of process engineering principles such as process flows, equipment sizing, and process optimization is important. Familiarity with cGMP requirements for aseptic manufacturing across multiple regulatory authorities, including EU and FDA, and understanding of the latest EU Annex 1 requirements and their effect on facility and equipment design is needed. The role also requires the ability to support technology transfer and manufacturing readiness, along with strong organization, coordination, communication, stakeholder management, troubleshooting, and process improvement capabilities.

Additional information

This position is based in Riyadh, Saudi Arabia and is a full-time onsite role. Salary details were not provided.