Manufacturing Engineer

Stark Pharma Solutions Inc; Springfield (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a motivated Manufacturing Engineer with 0-1 year of experience to support pharmaceutical operations. 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.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical, Biomedical Engineering or related field.
• 0–1 year of experience through internships, co-op, academic projects, or entry-level roles in 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 and equipment qualification is a plus.

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.

Skills

Analytical skills

Communication skills

Cross-functional teamwork

Microsoft Office

Eagerness to learn

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Chemical/Biomedical Engineering or related

Tools

Microsoft Office

Job description

Job Title

Manufacturing Engineer

Location

USA

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.