Job Title: Process Development Engineer (Manufacturing / Lab Scale)Job Summary
We are seeking a skilled Process Development Engineer to lead the development, optimization, and scale-up of manufacturing processes within a laboratory and pilot-scale environment. The role involves designing robust, efficient, and compliant processes using data-driven methodologies, and supporting technology transfer into production.
Key Responsibilities
- Lead the development and scale-up of manufacturing processes from lab to pilot and commercial scale.
- Design and optimize manufacturing processes using statistics-based experimentation and process excellence principles.
- Drive new product scale-up activities, including purification, process optimization, and validation.
- Support technology transfer from development to production environments.
- Develop and document production procedures, batch records, and product specifications.
- Monitor process and equipment performance; identify gaps and implement continuous improvement initiatives.
- Collaborate with internal cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure process efficiency and compliance.
- Work closely with external vendors and equipment suppliers to define, procure, install, and qualify manufacturing equipment.
- Develop custom pilot-scale and commercial manufacturing equipment where required.
- Ensure all manufacturing processes comply with regulatory standards and company policies.
- Participate in process validation and qualification activities.
Qualifications & Education
- Bachelor’s or Master’s Degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related field.
- Postgraduate certifications or specialized training may be advantageous (as per role requirements).
Experience
- Minimum 4+ years of relevant experience in process development, scale-up, or manufacturing within a laboratory or pilot-scale environment.
- Experience in industries such as pharmaceuticals, biotech, specialty chemicals, or related fields is preferred.
Key Skills & Competencies
- Strong knowledge of process development, scale-up, and technology transfer.
- Expertise in Design of Experiments (DoE) and statistical analysis.
- Familiarity with process validation, regulatory requirements (e.g., GMP), and quality standards.
- Hands-on experience with pilot-scale and commercial manufacturing equipment.
- Strong analytical, troubleshooting, and problem-solving skills.
- Effective collaboration and stakeholder management abilities.
- Continuous improvement mindset with focus on operational excellence.
Preferred Skills
- Experience in purification processes and product isolation techniques.
- Exposure to process automation and control systems.
- Knowledge of equipment qualification (IQ/OQ/PQ).
Pay: $40.00-$41.90 per hour
Work Location: In person
