CP Process Engineer

 DP Process Engineer Department

Overview We are seeking an experienced DP Process Engineer to support the introduction, tech transfer, and manufacturing readiness of new drug product (DP) processes within a biologics fill–finish environment. The successful candidate will play a key role in process development, facility fit assessments, risk evaluations, documentation creation, and technical support during GMP manufacturing.

This position requires strong technical capability, excellent problem-solving skills, and the ability to collaborate effectively across Operations, Quality, and global scientific teams.

Key Responsibilities

Process Development & Technical Transfer

• Perform gap analyses, facility fit studies, process safety reviews, and risk assessments for New Product Introductions (NPI).
• Assist in developing and optimizing manufacturing processes for new biologic products.
• Support technical transfer activities including process assessments, cleaning assessments, and documentation readiness.
• Monitor and analyze process performance data during manufacturing campaigns.

Technical Support & Troubleshooting

• Provide operational technical support for process deviations and issue resolution.
• Lead or assist investigations, root-cause analysis, and implementation of process improvements.
• Prepare, maintain, and update specifications for NPI materials, components, and consumables.

Documentation & Risk Management

• Lead or support PFMEA, EHS, and other process risk assessments.
• Develop NPI-related documentation such as transfer plans, protocols, procedures, and manufacturing batch records.

Collaboration & Training

• Work closely with cross-functional and global teams throughout process development and NPI execution.
• Support, train, and supervise operations personnel on new processes and procedures.
• Ensure adherence to all EHS&E standards, policies, and procedures.

Essential Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Experience with biologics DP fill–finish processes.
• Experience with lyophilized (LYO) products.
• Experience supporting technical transfer activities (e.g., gap assessments, cleaning assessments).
• Familiarity with single-use system design for DP operations.

Desired Requirements

• Master’s degree in a relevant technical discipline (preferred).
• Minimum 3 years’ experience in pharmaceutical or biologics process engineering, including scale-up and tech transfer in a cGMP environment.
• Experience with new product introductions in biologics manufacturing.

Additional Skills

• Minimum 1 year in a similar role within the pharmaceutical or biopharmaceutical industry.
• Strong technical and operational understanding of fill–finish unit operations.
• Excellent analytical, communication, and cross-functional collaboration skills.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.