Manufacturing Engineer

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Manufacturing Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

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.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

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