Senior Process Development Engineer

Olon Ricerca Bioscience Llc; Concord (OH); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Olon Ricerca Bioscience Llc in Concord, OH seeks a Senior Process Development Engineer to translate laboratory-scale processes into safe, executable manufacturing instructions for scale-up in a small molecule API facility.

The role spans kilo lab, plant, and HPAPI production, with guidance to other engineers on the team. The role requires collaboration with Chemistry, Quality, and Operations to develop batch records and ensure safety and compliance.

Qualifikationen

• Education: B.S. or M.S in Chemical Engineering or Chemistry.
• Experience: Ten+ years in scale-up/preparation of pharmaceutical and specialty chemicals.
• Strong knowledge of chemical process scale-up, mass/energy balances, and process safety management.
• Ability to work in a multi-disciplinary team and manage multiple tasks.

Aufgaben

• New Process Scale-Up & Execution: translate processes into batch records and guide operators.
• Documentation & Safety Compliance: prepare processing docs, safety reviews, and risk mitigation.
• Technical Troubleshooting & Client Interaction: troubleshoot deviations and communicate milestones to clients.

Kenntnisse

Collaborative nature

Process scale-up

Technical documentation

Mass/energy balances

Process safety management

Ausbildung

B.S. or M.S in Chemical Engineering or Chemistry

Ten+ years of scale-up experience in pharma

Jobbeschreibung

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Senior Process Development Engineer

Full Time Other Professional-B Concord, OH, US

2 days ago Requisition ID: 1133

Senior Process Development Engineer

Job Overview

We are seeking a detail-oriented and proactive Senior Process Development Engineer to join our team. This role focuses on the translation of new laboratory-scale chemical processes into safe, executable manufacturing instructions for scale-up within a small molecule API production facility. The ideal candidate will be flexible to adapt across kilo lab, plant, and HPAPI production areas and provide guidance to other team members.

Key Responsibilities

New Process Scale-Up & Execution

• Process Translation & Instructions: Interact closely with chemists to understand new chemical processes, translate them into executable instructions (batch records), and guide operators through initial production.
• Kilo lab or Plant Scaling: Learn and scale up production processes from the laboratory to the kilo lab or plant infrastructure, troubleshooting and adapting techniques when small molecule processes do not scale as expected. Assist other engineers with addressing challenging scale up situations.
• HPAPI Production:Be able to support HPAPI production processes and be the site’s subject matter expert.
• Operational Supervision: Oversee the execution of processing, participate on the production floor as appropriate, and review executed batch records to ensure technical compliance.

Documentation & Safety Compliance

• Supporting Documentation: Author, review, and organize necessary processing documentation, including batch records, deviations, material specifications, hazard sheets, air emissions data, and processing reports.
• Safety & Risk Mitigation: Conduct process safety meetings, develop safety review packages, and ensure all scaling activities strictly adhere to plant safety protocols.
• Cross-Functional Collaboration: Interact closely with Chemistry, Quality, and Operations departments throughout the production lifecycle, while managing external interactions with vendors and contractors.

Technical Troubleshooting & Client Interaction

• Process Troubleshooting: Apply development troubleshooting and problem-solving skills to identify, investigate, and resolve process deviations or scaling anomalies directly on the shop floor.
• Client Status Updates: Act as a key technical point of contact for clients, hosting regular project status updates, delivering tech transfer summaries, and communicating technical milestone progressions clearly.
• Infrastructure Support: Provide day-to-day chemical engineering support for the maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.

Required Skills & Qualifications

• Education: B.S. or M.S in Chemical Engineering or Chemistry
• Experience: Ten or more years of experience in scale-up/preparation of pharmaceutical and specialty chemicals
• Technical Competencies: Strong foundational knowledge of chemical process scale-up, mass/energy balances, process safety management, and technical document authoring.
• Collaborative Nature: Exhibits effective time management and a strong multi-tasking mindset to self-manage assigned tasks, drive projects to completion, and work effectively in a multi-disciplinary team environment.