Job Title: Process Engineer

Job Description

As a Process Engineer, you will be a key technical contributor in the transfer, development, and continuous improvement of biologics manufacturing processes. You will collaborate across departments to ensure successful clinical and commercial production while maintaining compliance with GMP standards.

Responsibilities

• Develop and improve biologics manufacturing processes.
• Collaborate with cross-functional teams to ensure successful production outcomes.
• Maintain compliance with GMP standards and regulatory requirements.
• Utilize chromatography techniques for process development.
• Document and communicate technical information effectively.
• Mentor junior engineers or technicians.

Essential Skills

• Bachelor’s degree in Chemical Engineering, Biochemistry, or related scientific field.
• 4+ years of experience in GMP-regulated biologics or pharmaceutical manufacturing.
• Strong understanding of cGMP and regulatory requirements (US/EU).
• Proficiency in Microsoft Word and Excel.
• Excellent communication and documentation skills.
• Ability to work independently and in cross-functional teams.

Additional Skills & Qualifications

• Familiarity with statistical methods for process analysis.
• Experience with upstream and downstream processing.
• Knowledge of Chemistry, Manufacturing, and Controls (CMC) principles.
• Experience mentoring junior engineers or technicians.
• Senior Level: A Master's degree with slightly less experience, or a PhD with at least three years of experience.

Work Environment

The role requires gowning into ISO spaces, including removing earrings, cosmetics, and hair products at least once a week. You will be on the manufacturing floor approximately 25% of the time in a client-facing capacity, working on a dedicated client program.