Senior Pharmaceutical Process Development Engineer - Remote

Placements24; Southampton; Híbrido; GBP 85 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health, dental, and vision insurance

Retirement plan

Annual bonuses

Training & certifications

Conferences access

Home office setup

Resumo da oferta

Placements24 is recruiting a Senior Pharmaceutical Process Development Engineer for a fully remote position in the UK. You will lead the design, optimization, and scale‑up of manufacturing processes for novel pharmaceutical products, translating lab work to commercial manufacturing.

You will collaborate with R&D, manufacturing, and quality teams to meet regulatory requirements, drive process innovation, and maintain state‑of‑the‑art capabilities.

Qualificações

• 7–10 years of progressive experience in pharmaceutical process development and scale-up.
• Strong understanding of pharmaceutical manufacturing principles, unit operations and equipment.
• Experience in process validation and technology transfer in GMP environments.
• Knowledge of regulatory guidelines (ICH, FDA) for pharmaceutical manufacturing.
• Ability to model and simulate processes and apply SPC.

Responsabilidades

• Lead development and optimization of robust, scalable manufacturing processes for drug substances/products.
• Design experiments to understand CPPs and CQAs.
• Develop process models and simulations to predict performance and identify improvements.
• Execute technology transfer from R&D to manufacturing, scale-up.
• Troubleshoot and resolve complex process issues in development and manufacturing.
• Prepare process development reports, validation protocols, and regulatory documentation.
• Collaborate with Formulation, Analytical Development, Manufacturing Operations, and QA.
• Ensure compliance with GMP and regulatory requirements.
• Evaluate new technologies and equipment to enhance capabilities.
• Mentor junior engineers and manage project timelines/resources.

Conhecimentos

Process modeling

Simulation

SPC

GMP experience

Project leadership

Analytical/problem-solving

Communication

Independent remote work

Formação académica

Bachelor's or Master's in Chemical/Pharmaceutical/Mechanical Engineering

Related discipline

Ferramentas

Aspen Plus

JMP

Minitab

Descrição da oferta de emprego

About the Role

Our client, a leader in pharmaceutical innovation, is actively seeking a highly experienced Senior Pharmaceutical Process Development Engineer for a fully remote position. This role is pivotal in the design, optimization, and scale‑up of manufacturing processes for novel pharmaceutical products. You will be instrumental in ensuring that our client's innovative drug candidates can be manufactured efficiently, reliably, and to the highest quality standards. The ideal candidate possesses a strong engineering background, extensive experience in pharmaceutical process development, and a proven ability to translate laboratory‑scale processes to commercial manufacturing. You will collaborate with research, development, manufacturing, and quality teams to overcome complex technical challenges and ensure regulatory compliance. This remote position requires exceptional self‑management, communication skills, and the ability to contribute significantly to project success without direct on‑site supervision. You will drive process innovation and ensure our client's manufacturing capabilities remain state‑of‑the‑art, supporting their mission to deliver life‑changing medicines to patients worldwide.

Key Responsibilities

• Lead the development and optimization of robust and scalable manufacturing processes for pharmaceutical drug substances and/or drug products.
• Design and execute experiments to understand process parameters, critical process parameters (CPPs), and critical quality attributes (CQAs).
• Develop process models and simulations to predict process performance and identify areas for improvement.
• Conduct technology transfer activities from R&D to manufacturing, ensuring successful implementation at scale.
• Troubleshoot and resolve complex process‑related issues encountered during development, scale‑up, and commercial manufacturing.
• Author and review process development reports, validation protocols, and regulatory submission documents (e.g., CMC sections).
• Collaborate with cross‑functional teams, including Formulation, Analytical Development, Manufacturing Operations, and Quality Assurance.
• Ensure all process development activities comply with relevant GMP guidelines and regulatory requirements.
• Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities.
• Mentor junior engineers and provide technical guidance on process development best practices.
• Manage project timelines and resources effectively to meet company objectives.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related discipline.
• Minimum of 7-10 years of progressive experience in pharmaceutical process development and scale‑up.
• Deep understanding of pharmaceutical manufacturing principles, unit operations, and associated equipment.
• Proven experience in process validation, technology transfer, and GMP environments.
• Strong knowledge of regulatory guidelines (e.g., ICH, FDA) pertaining to pharmaceutical manufacturing.
• Expertise in process modeling, simulation, and statistical process control (SPC) is highly desirable.
• Excellent analytical, problem‑solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to present complex technical information clearly.
• Proven ability to lead projects and collaborate effectively in a cross‑f.
• Proficiency in relevant software tools (e.g., Aspen Plus, JMP, Minitab) is advantageous.
• Demonstrated ability to work independently and drive results in a remote work environment.

Benefits

Our client offers a highly competitive salary and a comprehensive benefits package, including excellent health, dental, and vision insurance, a strong retirement plan, and annual performance bonuses. This fully remote role provides exceptional flexibility and autonomy, allowing for a superior work‑life balance. Our client is committed to the professional development of its employees, offering extensive training opportunities, support for professional certifications, and access to leading industry conferences. You will be part of an innovative company culture that values scientific rigor and continuous improvement, contributing to the development of life‑saving medicines. Our client provides resources for home office setup to ensure you have a productive and comfortable working environment. Career advancement opportunities within their global operations are readily available for high achievers.