Process Engineer

About the role

The Senior Process Engineer is responsible for developing, scaling, validating, and optimizing manufacturing processes for a commercial-scale biopharmaceutical facility. This role ensures process robustness, compliance with cGMP standards, and successful technology transfer from development to commercial production.

Responsibilities

• Develop, scale, validate, and optimize manufacturing processes for a commercial-scale biopharmaceutical facility.
• Ensure process robustness, compliance with cGMP standards, and successful technology transfer from development to commercial production.
• Act as a System Owner for designated equipment used in upstream or downstream operations.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, or related field.
• Minimum 8 years of relevant experience in process engineering, preferably in the biopharmaceutical industry.
• Experience with cGMP regulations and Good Manufacturing Practices (GMP).
• Strong knowledge of upstream and downstream processing techniques.
• Excellent problem-solving skills and ability to work independently and as part of a team.
• Ability to communicate effectively with cross-functional teams including R&D, manufacturing, and quality assurance.

Qualifications

• Proven track record of successfully managing complex projects from concept to implementation.
• Experience with process simulation software and data analysis tools.
• Knowledge of continuous manufacturing principles and technologies.
• Experience with regulatory submissions and compliance activities.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.
• Ability to work in a fast-paced, dynamic environment.

Benefits

• Health insurance
• Health savings account
• Retail savings plan
• Life and disability insurance
• Paid leave where required by applicable law

Pay

Commensurate with experience.

Schedule

N/A

Real

To find out more about Real, please visit www.realstaffing.com.