Manufacturing Engineer

Role summary

This opening is for an entry-level Manufacturing Engineer to support regulated production activities in the pharmaceutical, biotechnology, or medical device space. The position is intended for candidates with 0 to 1 year of experience, including recent graduates and those with internship or co-op exposure, who want to develop their careers in a compliance-driven manufacturing setting.

The role focuses on day-to-day production support, helping improve processes, assisting with equipment qualification and validation, maintaining technical documentation, and contributing to quality and compliance work alongside multiple internal teams.

Location: USA

Duration: Long Term

Key responsibilities

• Help keep manufacturing operations safe, efficient, and in line with required standards.
• Support ongoing efforts to refine processes and improve output quality and productivity.
• Assist with equipment setup, qualification, troubleshooting, and upkeep.
• Contribute to process validation, IQ/OQ/PQ activities, and related manufacturing records.
• Draft, update, and manage SOPs, work instructions, batch records, and engineering documents.
• Work with Manufacturing, Production, Quality Assurance, Validation, Engineering, and Regulatory groups.
• Gather and review production data to spot opportunities for process enhancement.
• Support deviation reviews, CAPA work, and change control documentation.
• Follow GMP, cGMP, FDA, ISO, and internal quality requirements.
• Take part in Lean Manufacturing and continuous improvement initiatives.

Qualifications

• A bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a closely related discipline is required.
• Experience of 0 to 1 year through internships, co-op assignments, academic projects, or entry-level work in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Working knowledge of manufacturing fundamentals and core engineering concepts.
• Exposure to GMP/cGMP, FDA rules, ISO 13485, or similar regulated manufacturing practices is preferred.
• Basic familiarity with process validation, equipment qualification, and quality systems is an advantage.
• Strong analytical thinking, troubleshooting ability, and problem-solving skills.
• Clear written and spoken communication skills.
• Comfort working in cross-functional teams.
• Good working knowledge of Microsoft Office tools.
• A strong willingness to learn and grow in a regulated manufacturing environment.

Additional information

This is a long-term opportunity shared by Stark Pharma Solutions Inc on behalf of its client. Candidates are expected to have relevant experience and share an updated resume if interested. The role is based in the USA and is being hired for current as well as upcoming opportunities.

Contact note

Applicants were asked to send an updated resume along with the best number and time to reach them for further discussion.