Process Engineer

Role Overview

As an integral part of the Technical Services team, the Technical Services Engineer – Product/Process supports the design, development, and enhancement of aseptic pharmaceutical manufacturing systems. This role ensures adherence to regulatory standards while fostering continuous process improvements and supports the transfer, qualification, and introduction of new products. Collaboration with teams across Production, Quality, Regulatory, and Engineering departments is critical to improve operational efficiencies, scale manufacturing, and resolve production challenges.

Key Responsibilities

• Design, develop, and refine pharmaceutical manufacturing processes to achieve consistent, scalable, and cost-effective outputs.
• Conduct process risk assessments such as Failure Mode and Effects Analysis (FMEA) and implement measures to mitigate identified risks.
• Lead root cause investigations and handle deviations and non-conformance issues effectively.
• Support scale-up initiatives, technical transfers, alternate source qualifications, and commercialization through study planning, protocol development, and result documentation.
• Develop and execute process validation protocols including process performance qualification (PPQ) and oversee continued process verification activities.
• Generate and manage change control documentation in compliance with site-specific procedures to facilitate product and process changes.
• Assure all process modifications comply with cGMP standards and regulatory requirements from FDA, EMA, and other agencies.
• Contribute process-related data and justifications to regulatory filings such as Chemistry, Manufacturing, and Controls (CMC) documentation.
• Provide on-site technical support for daily manufacturing operations, process anomalies, and troubleshooting.
• Collaborate closely with production and quality teams to maintain consistent process performance and improve process variability relating to critical quality attributes (CQAs).
• Assist with technology transfers across development, pilot, and commercial manufacturing scales ensuring smooth transitions.
• Define critical process parameters (CPPs) and CQAs necessary for successful process transfers and scale-up activities.
• Drive continuous improvement by applying Lean, Six Sigma, and other problem-solving strategies to enhance process efficiency and reduce waste.
• Evaluate and implement new technologies aimed at improving yield and operational cost-effectiveness without compromising quality and compliance.
• Perform additional responsibilities as assigned.

Qualifications and Experience

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related discipline.
• Between 3 to 7 years of experience within pharmaceutical manufacturing or process engineering environments, including a minimum of 2 years specifically with sterile injectables or biologics production.

Technical Competencies

• In-depth understanding of aseptic processing, terminal sterilization, and lyophilization methodologies.
• Experience with process validation protocols such as PPQ, Design of Experiments (DOE), and Statistical Process Control (SPC).
• Strong familiarity with cGMP practices and regulatory guidelines such as Annex 1, FDA, EMA, and ICH for sterile products.
• Competence in preparing necessary cGMP documentation including protocols, reports, and change control forms.
• Practical knowledge of equipment like filling machines, isolators, autoclaves, depyrogenation tunnels, lyophilizers and their operational parameters.
• Understanding of aseptic behavior, filter integrity testing, and single-use system technologies.
• Proficiency with data analysis software (e.g., Minitab) and process modeling tools.

Soft Skills

• Exceptional analytical and problem-solving aptitude.
• Effective communication and the ability to work collaboratively across multiple functional teams.
• Capacity to manage and prioritize several projects in a dynamic and fast-paced setting.

Preferred Additional Qualifications

• Certification in Six Sigma or Lean Manufacturing methodologies.
• Experience working with automation technologies such as SCADA and MES systems.
• Knowledge of Process Analytical Technology (PAT) implementations.