Operations Senior Specialist

Main Purpose:

The Operations Senior Specialist will support the development and execution of biologics and vaccine manufacturing capabilities by bridging process engineering, facility design, and operational readiness. The role will contribute to process definition and front-end engineering activities, ensuring that process requirements are translated into equipment, facility design, and operational workflows. In parallel, the role will provide support for operational readiness and technology transfer.

Area of Responsibility

:1. Process Engineering and Design Suppor

• tDevelop and Review process flow diagrams (PFDs), process descriptions, and mass/volume balances for biologics manufacturing processes based on the information provided by the sending unit
• .Assist in translating process requirements into equipment sizing, specifications, and facility design inputs
• .Contribute to 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 evaluation of process technologies, single-use systems, and equipment configurations

.
2. Front-End Engineering & RFP Suppo

• rtLead preparation of technical RFP/RFQ packages by compiling process and operational requirement
• s.Assist in development of process data sheets, technical inputs, and evaluation criteri
• a.Support coordination of vendor queries, clarifications, and bid documentatio
• n.Assist in reviewing and organizing vendor submissions and technical proposals for internal evaluatio
• n.Maintain trackers for RFP timelines, deliverables, and evaluation input

s.
3. Operational Supp

• ortSupport implementation of the operational readiness plan for greenfield manufacturing site readine
• ss.Support execution of technology transfer activities, ensuring alignment between transferred process and facility capabiliti
• es.Support coordination meetings and maintain action trackers across workstrea
• ms.Support readiness for process validation and regulatory inspectio

ns.
Educational Qualificat

• ion:Bachelor's degree in Chemical/Biochemical Engineering or a related scientific discipl
• ine.Hands on experience/ training in pharmaceutical manufacturing, or biotechnology is a m

ust.
Work Experi

• ence:5-6 years of experience in pharmaceutical or biopharmaceutical manufacturing environm
• ents.Experience in process engineering, MSAT, or manufacturing support r
• oles.Experience supporting facility design, equipment specification, or engineering proj
• ects.Exposure to GMP environments and drug product manufacturing operat
• ions.Experience in RFP processes, vendor coordination, or technical documentation prepara
• tion.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 desir

able.
Required S

• kills:Strong understanding of biologics and/or vaccine manufacturing processes for drug product (fill-finish) operations, and ability to translate process requirements into facility and equipment design i
• nputs.Familiarity with process engineering concepts, including process flows, equipment sizing, and process optimiz
• ation.cGMP's for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment
• designAbility to support technology transfer and manufacturing readiness activ
• ities.Strong organizational and coordination skills with ability to manage multiple workst
• reams.Good communication and stakeholder coordination skills in cross-functional environ
• ments.Problem-solving mindset with ability to support troubleshooting and process improve