Senior Process Engineer I, Material Science - Remote

Overview

This position requires the utilization of expertise relevant to biopharmaceutical materials and processes with an emphasis on single use technologies (bags, filters, tubing assemblies, drug product materials) and may also include support of chemical raw materials (chemicals, media, resin). Technical expertise in biopharmaceutical manufacturing materials is required to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations.

In Short

• Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives.
• Assist in the development of site/company standard raw material platforms.
• Assess raw material supplier change notifications and complaints.
• Support investigations into raw material deviations.
• Evaluate and/or test the feasibility of new manufacturing raw materials.
• Participate in small-scale validation studies.
• Responsible for technical evaluation of proposed raw material changes.
• Support technology and process transfer to Manufacturing areas.
• Manage raw material change requests via Veeva QMS.
• Oversee project milestones and departmental goals.

Requirements

• 5+ years of relevant industry experience in pharmaceutical or biopharmaceutical production.
• 2+ years of experience in formal project management.
• Strong knowledge of pharmaceutical raw materials.
• Established working relationship with raw material suppliers.
• Basic understanding of biopharmaceutical processes.
• Strong technical understanding of biopharmaceutical manufacturing processes.
• Experience in the transfer of processes to cGMP operations.
• Knowledge of chemical raw material standards.
• Understanding of FDA and European regulatory requirements.
• Proven project management and communication skills.

Benefits

• Collaborative work environment.
• Opportunities for professional development.
• Engagement in innovative science.
• Flexible work schedule.
• Participation in relevant professional conferences.