Manufacturing Engineer (Entry Level)

About the role

We are looking for a motivated Manufacturing Engineer to join our client’s regulated manufacturing team in the United States. This entry‑level position is ideal for recent graduates or candidates with internship experience who want to start a career in pharmaceutical, biotechnology, or medical‑device manufacturing.

Key responsibilities

• Support daily manufacturing operations to ensure safe, efficient, and compliant production.
• Assist in monitoring and improving processes to boost productivity and product quality.
• Help with equipment installation, qualification, troubleshooting, and maintenance.
• Participate in process validation and equipment qualification (IQ/OQ/PQ) activities.
• Prepare and maintain SOPs, work instructions, batch records, and other engineering documentation.
• Collaborate with Manufacturing, Quality Assurance, Validation, Engineering, and Regulatory teams.
• Collect and analyze manufacturing data to identify improvement opportunities.
• Support deviation investigations, CAPA actions, and change‑control documentation.
• Ensure compliance with GMP, cGMP, FDA, ISO standards, and company quality procedures.
• Contribute to Lean Manufacturing and continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Chemical, Biomedical Engineering or a related discipline.
• 0‑1 year of experience through internships, co‑ops, academic projects, or entry‑level roles in regulated manufacturing.
• Basic understanding of manufacturing processes, GMP/cGMP, and FDA regulations.
• Strong analytical, troubleshooting, and problem‑solving abilities.
• Excellent written and verbal communication skills.
• Ability to work effectively in cross‑functional teams.
• Eagerness to learn and grow in a regulated environment.

Required skills

• Proficiency with Microsoft Office applications.