Pharma Equipment Engineer - cGMP & Process Optimization

SciGen Pte. Ltd.; Hauppauge (NY); Hybrid; USD 74,000 - 90,000; Full time

Job summary

Sciegen Pharmaceuticals Inc. in Hauppauge, NY seeks an Equipment Engineer to analyze requirements and design/update operating and maintenance processes for its advanced manufacturing equipment.

You will monitor internal engineering projects, perform root-cause analysis, develop maintenance solutions, and ensure cGMP, US FDA and OSHA compliance, working with vendors on custom solutions and facilitating equipment qualification activities (IQ/OQ/PQ).

Qualifications

• Bachelor’s degree in mechanical engineering or related field required.
• Minimum 2 years of pharmaceutical industry experience.
• Experience with cGMP, IQ/OQ/PQ protocols.
• Ability to analyze requirements and design/upgrade maintenance processes.

Responsibilities

• Analyze requirements and design/update operating and maintenance processes for equipment.
• Assist in monitoring internal engineering projects and design modifications.
• Develop maintenance solutions and perform root-cause analysis.
• Prepare IQ/OQ/PQ protocols and reports per cGMP requirements.
• Consult with vendors to develop custom equipment solutions and layouts.
• Ensure compliance with US FDA, OSHA guidelines and related standards.

Skills

Equipment design

Root-cause analysis

Vendor collaboration

Process improvement

Education

Bachelor's degree in Mechanical Engineering

Tools

CAD

Job description

Sciegen Pharmaceuticals Inc. in Hauppauge, NY seeks an Equipment Engineer to analyze requirements and design/update operating and maintenance processes for its advanced manufacturing equipment.

You will monitor internal engineering projects, perform root-cause analysis, develop maintenance solutions, and ensure cGMP, US FDA and OSHA compliance, working with vendors on custom solutions and facilitating equipment qualification activities (IQ/OQ/PQ).