Operations Senior Specialist📣 Job Ad

About the Role

Lifera is seeking a motivated Operations Senior Specialist to join our team in Riyadh, Saudi Arabia. This role is central to developing and executing our biologics and vaccine manufacturing capabilities. The Operations Senior Specialist will serve as a key liaison between process engineering, facility design, and operational readiness, ensuring that complex process requirements are translated into tangible equipment, facility designs, and streamlined operational workflows. This position offers an opportunity to contribute to the establishment of advanced manufacturing facilities and support critical technology transfer initiatives.

The role requires a proactive approach to process definition, front-end engineering activities, and a strong focus on operational readiness. You will be instrumental in ensuring our manufacturing processes are robust, compliant, and prepared for large-scale production.

Key Responsibilities

• Develop and review process flow diagrams (PFDs), process descriptions, and mass/volume balances for biologics manufacturing processes based on information provided by the sending unit.
• Assist in translating process requirements into equipment sizing, specifications, and facility design inputs.
• Contribute to the development of User Requirement Specifications (URS) and technical specifications for process equipment and manufacturing areas.
• Participate in design reviews to ensure alignment between process requirements and facility layout, cleanroom zoning, and utilities.
• Support the evaluation of process technologies, single-use systems, and equipment configurations.
• Lead the preparation of technical Request for Proposal (RFP)/Request for Quotation (RFQ) packages by compiling process and operational requirements.
• Assist in the development of process data sheets, technical inputs, and evaluation criteria.
• Support the coordination of vendor queries, clarifications, and bid documentation.
• Assist in reviewing and organizing vendor submissions and technical proposals for internal evaluation.
• Maintain trackers for RFP timelines, deliverables, and evaluation input.
• Support the implementation of the operational readiness plan for greenfield manufacturing site readiness.
• Support the execution of technology transfer activities, ensuring alignment between transferred processes and facility capabilities.
• Support coordination meetings and maintain action trackers across workstreams.
• Support readiness for process validation and regulatory inspections.

Qualifications and Requirements

• Bachelor's degree in Chemical/Biochemical Engineering or a related scientific discipline.
• Hands-on experience or training in pharmaceutical manufacturing or biotechnology is required.
• 5-6 years of experience in pharmaceutical or biopharmaceutical manufacturing environments.
• Experience in process engineering, MSAT, or manufacturing support roles.
• Experience supporting facility design, equipment specification, or engineering projects.
• Exposure to Good Manufacturing Practice (GMP) environments and drug product manufacturing operations.
• Experience in RFP processes, vendor coordination, or technical documentation preparation.
• Knowledge or exposure to cell and gene therapy (CGT) is considered a plus.
• Experience working in project management roles or within capital project environments, including coordination of multi-disciplinary teams, is highly desirable.

Required Skills

• Strong understanding of biologics and/or vaccine manufacturing processes for drug product (fill-finish) operations, with the ability to translate process requirements into facility and equipment design inputs.
• Familiarity with process engineering concepts, including process flows, equipment sizing, and process optimization.
• Proficiency in current Good Manufacturing Practices (cGMP) for aseptic manufacturing across multiple regulatory bodies (EU, FDA), including a fluent understanding of new EU Annex 1 guidelines and their impact on facility/equipment design.
• Ability to support technology transfer and manufacturing readiness activities.
• Strong organizational and coordination skills with the ability to manage multiple workstreams effectively.
• Good communication and stakeholder coordination skills in cross-functional environments.
• A problem-solving mindset with the ability to support troubleshooting and process improvement initiatives.

Work Environment and Location

This is a full-time position based in Riyadh, Saudi Arabia. The role involves contributing to the establishment of state-of-the-art manufacturing facilities and supporting critical technology transfer initiatives.