Process Engineer

We are seeking an experienced Process Engineer to join our team for a pharmaceutical manufacturing facility build project. The ideal candidate will have a strong background in process engineering within the pharmaceutical or biotech industry, with expertise in designing, optimizing, and validating production processes. You will be responsible for ensuring that the facility’s production processes are efficient, compliant, and aligned with industry standards and project specifications.

Key Responsibilities

Process Design and Optimization: Develop and design manufacturing processes that meet project and regulatory requirements. Ensure process scalability, efficiency, and safety for the production of pharmaceutical products.
Equipment Selection and Layout: Work closely with the facility design team to select appropriate equipment, design facility layout, and ensure integration of process systems. Consider process flow, equipment specifications, and operational efficiency.
Project Collaboration: Collaborate with project managers, automation engineers, validation teams, and vendors to ensure seamless execution of the project from design through to commissioning.
Regulatory Compliance: Ensure that all process designs and implementations comply with FDA regulations, Good Manufacturing Practices (GMP), and other relevant industry standards. Participate in audits and regulatory inspections as needed.
Process Validation: Develop and execute validation protocols (IQ/OQ/PQ) to ensure that manufacturing processes meet quality standards and regulatory requirements. Oversee the execution of validation studies and document results.
Troubleshooting and Continuous Improvement: Identify and resolve process inefficiencies or technical issues. Work towards continuous improvement initiatives by identifying optimization opportunities to enhance production quality, reduce costs, and improve yield.
Documentation and Reporting: Create and maintain detailed documentation of process designs, validation protocols, test results, and process changes. Prepare regular project status reports for stakeholders.
Training and Support: Provide guidance and support to operations teams on new process implementations. Develop and deliver training programs to ensure smooth knowledge transfer to facility personnel.

Requirements

Qualifications

Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field. Advanced degrees or relevant certifications (e.g., PE) are a plus.
Minimum of 10 years of experience in process engineering within the pharmaceutical, biotech, or related manufacturing industry. Proven experience with process design, optimization,
and validation in a GMP environment.
Strong knowledge of pharmaceutical manufacturing processes, equipment selection, and process validation. Experience with process simulation software, equipment sizing, and risk-
based process development.
Familiarity with FDA regulations, GMP, and ICH guidelines. Experience with process validation, technology transfer, and regulatory compliance.

Preferred Qualifications

Experience with upstream and downstream biopharmaceutical processes.
Project management experience or certifications (e.g., PMP).
Experience with Lean, Six Sigma, or other process improvement methodologies.

Soft Skills

Cross-Cultural Communication
Adaptability and Flexibility
Team Collaboration and Interdisciplinary Skills
Problem-Solving and Critical Thinking
Emotional Intelligence
Time Management and Prioritization
Ethical Awareness and Sustainability Focus
Conflict Management
Stakeholder Engagement
Continuous Learning Mindset

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General Information

Vacancy: 018

Location: Europe

Contract type: 1 year rolling contract, consulting contract.

Project duration: 1-2 years.

How to Apply?

If you’re interested in this role, we’re looking forward to hear from you! Kindly apply via the JTR Consultancy Services website with your CV in Word Document version – one of our Business Development Managers will be in touch with you shortly.