Manufacturing Engineer

Stark Pharma Solutions Inc; Orlando (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an entry-level Manufacturing Engineer in Orlando, FL. The role supports daily manufacturing operations and works within a regulated pharmaceutical/biotech setting.

The candidate will assist with process improvements, equipment qualification, documentation, and quality compliance, collaborating with QA, Validation, and Regulatory teams.

Qualifications

• Bachelor's degree in an engineering discipline (Mechanical, Manufacturing, Industrial, Chemical, Biomedical) or closely related field.
• 0-1 year of experience through internships, co‑op programs, academic projects, or entry‑level roles in regulated manufacturing environments.
• Familiarity with GMP/cGMP, FDA regulations, ISO 13485, or regulated manufacturing practices preferred.
• Knowledge of process validation and equipment qualification is a plus.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Excellent written and verbal communication; ability to work cross-functionally.

Responsibilities

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

Skills

Analytical thinking

Troubleshooting

Documentation

Cross-functional teamwork

Communication

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Biotechnology

Tools

Microsoft Office

Job description

Job Title

Manufacturing Engineer

Location

Orlando, FL

Duration

Long Term

Position Overview

We are seeking a motivated Manufacturing Engineer with 0 1 year of experience to support manufacturing operations within the pharmaceutical, biotechnology, or medical device industry. This entry‑level role is ideal for recent graduates or candidates with internship or co‑op experience who are eager to build a career in regulated manufacturing. The selected candidate will assist with process improvements, manufacturing support, equipment qualification, documentation, and quality compliance while working closely with cross‑functional teams.

Key Responsibilities

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

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related engineering discipline.
• 0 1 year of experience through internships, co‑op programs, academic projects, or entry‑level roles in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Basic understanding of manufacturing processes and engineering principles.
• Familiarity with GMP/cGMP, FDA regulations, ISO 13485, or regulated manufacturing practices is preferred.
• Basic knowledge of process validation, equipment qualification, and quality systems is a plus.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross‑functional team environment.
• Proficiency in Microsoft Office applications.
• Eagerness to learn and grow in a regulated manufacturing environment.